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A Clinical Trial to Evaluate the Safety and the Pharmacokinetic Interaction of Telmisartan and Dapagliflozin.

Primary Purpose

Hypertension, Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
THP-00101 (Dapagliflozin) 10mg
THP-00102 (Telmisartan) 80mg
Sponsored by
THPharm Corp.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: A person who is 19 years of age or older at the screening visit A person who weighs at least 55 kg (50 kg for women) and has a body mass index (BMI) of at least 18.0 kg/m2 and at least 30.0 kg/m2 at screening visit ☞ BMI (kg/m2) = Weight (kg)/ {Height (m)}2 A person who has no clinically meaningful congenital or chronic disease and has no pathological symptoms or findings as a result of medical examination at a screening visit A person who has been determined to be suitable for the test as a result of diagnostic tests such as hematology tests, hematochemical tests, serum tests, urine tests, etc., set and conducted by the test manager (or delegated test doctor) according to the characteristics of clinical drugs A person who agrees to exclude the possibility of pregnancy using a medically recognized contraceptive method* (except hormones) and does not provide sperm or eggs from the date of first administration of the clinical trial drug to 14 days after the date of last clinical trial drug administration *medically-accepted Contraceptive methods: a combination of intrauterine devices, vasectomy, tubular ligation, and blocking contraception (male condoms, female condoms, cervical caps, contraceptive septum, sponge, etc.) or a combination of two or more blocking contraceptives A person who has received and understood sufficient explanation of the purpose, contents, characteristics of clinical trial drugs, expected abnormal cases, etc., and signed the consent form according to his/her free will Exclusion Criteria: A person who has or has a history of clinically significant diseases corresponding to the digestive system, cardiovascular system, endocrine system, respiratory system, blood and tumor, infectious disease, kidney and urinary system, mental and nervous system, musculoskeletal system A person who has a history of gastrointestinal surgery (excluding simple appendectomy or hernia surgery) or has gastrointestinal diseases that may affect drug absorption Those who have taken drug metabolism-inducing and inhibiting drugs such as barbital drugs within one month of the first administration date, or drugs that may interfere with this clinical trial within 10 days of the first administration (however, in consideration of pharmacokinetic and pharmacokinetic characteristics of combination drugs it may consider as possible) A person who participates in other clinical trials or biological equivalence tests within six months of the first administration and administered clinical trial drugs A person who has donated whole blood within 8 weeks of the first administration, donated ingredients within 2 weeks or received a blood transfusion within 4 weeks from the first administration A person who meets the following conditions within one month of the first dose date Men consume an average of 21 cups/week of alcohol Women consume an average of 14 cups/week of alcohol (1 glass = 50mL of soju, 30mL of spirits, or 250mL of beer) An average of more than 20 cigarettes a day A patient who falls under the following Patients with a history of hypersensitivity to the main ingredient or additive of this drug Type 1 diabetes patient with diabetic ketoacidosis Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption A patient on dialysis Patients with severe liver disorders, biliary obstruction, or bile congestion (mostly this drug is excreted as bile). A decrease in liver cleaning rate can be expected in patients with bile congestion, biliary obstruction disease, or liver failure.) Patients with hereditary angioedema, or patients with a history of angioedema when treated with ACE inhibitors or angiotensin II receptor antagonists Combination with aliskiren-containing preparations in patients with diabetes or moderate to severe renal disabilities (glomerular filtration rate <60mL/min/1.73m2) For reasons other than the above selection and exclusion criteria, the person in charge of testing (or the delegated test doctor) determines that he/she is not suitable for participation in this clinical trial In the case of female volunteers, those suspected of being pregnant or nursing

Sites / Locations

  • H Plus Yangji HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dapagliflozin

Telmisartan

Arm Description

THP-00101 (Dapagliflozin) 10mg (18 Subjects): Tx A (5 days) -> Tx B (5 days) Treatment A: THP-00101 (Dapagliflozin) 10mg/5 days Treatment B: THP-00101 (Dapagliflozin) 10mg/5 days + THP-00102 (Telmisartan) 80mg/5 days

THP-00102 (Telmisartan) 80mg (32 Subjects): Tx C (5 days) -> Tx B (5 days) Treatment C: THP-00102 (Telmisartan) 80mg/5 days Treatment B: THP-00102 (Telmisartan) 80mg/5 days + THP-00101 (Dapagliflozin) 10mg/5 days

Outcomes

Primary Outcome Measures

Pharmacokinetics - AUCτ,ss
AUCτ,ss of Dapagliflozin & Telmisartan
Pharmacokinetics - Cmax,ss
Cmax,ss of Dapagliflozin & Telmisartan
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Evaluate incidents rate of Adverse Event of Treatment-Emergent Adverse Event and compare concomitant medication usage

Secondary Outcome Measures

Pharmacokinetics - Tmax,ss
Tmax,ss of Dapagliflozin & Telmisartan
Pharmacokinetics - Cmin,ss
Cmin,ss of Dapagliflozin & Telmisartan
Pharmacokinetics - CLss/F
CLss/F of Dapagliflozin & Telmisartan
Pharmacokinetics - Vdss/F
Vdss/F of Dapagliflozin & Telmisartan
Pharmacokinetics - PTF
Peak-trough Fluctuation of Dapagliflozin & Telmisartan

Full Information

First Posted
September 8, 2023
Last Updated
September 25, 2023
Sponsor
THPharm Corp.
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1. Study Identification

Unique Protocol Identification Number
NCT06063109
Brief Title
A Clinical Trial to Evaluate the Safety and the Pharmacokinetic Interaction of Telmisartan and Dapagliflozin.
Official Title
A Two-arm, Open-label, Single-sequence, Multiple Oral Dosings, Crossover Clinical Trial to Evaluate the Safety and the Pharmacokinetic Interaction of THP-00101 and THP-00102 in Healthy Adult Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 9, 2023 (Anticipated)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
THPharm Corp.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study was designed to evaluate the safety and pharmacokinetic interaction between THP-00101 and THP-00102 in healthy adult volunteers.
Detailed Description
The study consists of 2 periods of THP-00101 or THP00102 administration over 5 days and combined administration of THP-00101 and THP00102 over 5 days in two arms. Dapagliflozin (18 Subjects): Tx A (5 days) -> Tx B (5 days) Treatment A: THP-00101 (Dapagliflozin) 1 tablet/5 days Treatment B: THP-00101 (Dapagliflozin) 1 tablet/5 days + THP-00102 (Telmisartan) 1 tablet/5 days Telmisartan (32 Subjects): Tx C (5 days) -> Tx C (5 days) Treatment C: THP-00102 (Telmisartan) 1 tablet/5 days Treatment B: THP-00102 (Telmisartan) 1 tablet/5 days + THP-00101 (Dapagliflozin) 1 tablet/5 days

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
A two-arm, open-label, single-sequence, multiple oral dosings, crossover clinical trials THP-00101 (Dapagliflozin) 10mg (18 Subjects): Tx A (5 days) -> Tx B (5 days) Treatment A: THP-00101 (Dapagliflozin) 10mg/5 days Treatment B: THP-00101 (Dapagliflozin) 10mg/5 days + THP-00102 (Telmisartan) 80mg/5 days THP-00102 (Telmisartan) 80mg (32 Subjects): Tx C (5 days) -> Tx B (5 days) Treatment C: THP-00102 (Telmisartan) 80mg/5 days Treatment B: THP-00102 (Telmisartan) 80mg/5 days + THP-00101 (Dapagliflozin) 10mg/5 days
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dapagliflozin
Arm Type
Experimental
Arm Description
THP-00101 (Dapagliflozin) 10mg (18 Subjects): Tx A (5 days) -> Tx B (5 days) Treatment A: THP-00101 (Dapagliflozin) 10mg/5 days Treatment B: THP-00101 (Dapagliflozin) 10mg/5 days + THP-00102 (Telmisartan) 80mg/5 days
Arm Title
Telmisartan
Arm Type
Experimental
Arm Description
THP-00102 (Telmisartan) 80mg (32 Subjects): Tx C (5 days) -> Tx B (5 days) Treatment C: THP-00102 (Telmisartan) 80mg/5 days Treatment B: THP-00102 (Telmisartan) 80mg/5 days + THP-00101 (Dapagliflozin) 10mg/5 days
Intervention Type
Drug
Intervention Name(s)
THP-00101 (Dapagliflozin) 10mg
Other Intervention Name(s)
Forxiga Tab. 10mg
Intervention Description
Dapagliflozin 10mg Tablet / 5 days in period 1 and period 2 will be given to Arm A Dapagliflozin 10mg Tablet / 5 days in period 2 will be given to Arm B
Intervention Type
Drug
Intervention Name(s)
THP-00102 (Telmisartan) 80mg
Other Intervention Name(s)
Micardis Tab. 80mg
Intervention Description
Telmisartan 80mg Tablet / 5 days in period 1 and period 2 will be given to Arm B Telmisartan 80mg Tablet / 5 days in period 2 will be given to Arm A
Primary Outcome Measure Information:
Title
Pharmacokinetics - AUCτ,ss
Description
AUCτ,ss of Dapagliflozin & Telmisartan
Time Frame
Day 1 to Day 11
Title
Pharmacokinetics - Cmax,ss
Description
Cmax,ss of Dapagliflozin & Telmisartan
Time Frame
Day 1 to Day 11
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Evaluate incidents rate of Adverse Event of Treatment-Emergent Adverse Event and compare concomitant medication usage
Time Frame
Day 1 to Day 17
Secondary Outcome Measure Information:
Title
Pharmacokinetics - Tmax,ss
Description
Tmax,ss of Dapagliflozin & Telmisartan
Time Frame
Day 1 to Day 11
Title
Pharmacokinetics - Cmin,ss
Description
Cmin,ss of Dapagliflozin & Telmisartan
Time Frame
Day 1 to Day 11
Title
Pharmacokinetics - CLss/F
Description
CLss/F of Dapagliflozin & Telmisartan
Time Frame
Day 1 to Day 11
Title
Pharmacokinetics - Vdss/F
Description
Vdss/F of Dapagliflozin & Telmisartan
Time Frame
Day 1 to Day 11
Title
Pharmacokinetics - PTF
Description
Peak-trough Fluctuation of Dapagliflozin & Telmisartan
Time Frame
Day 1 to Day 11

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: A person who is 19 years of age or older at the screening visit A person who weighs at least 55 kg (50 kg for women) and has a body mass index (BMI) of at least 18.0 kg/m2 and at least 30.0 kg/m2 at screening visit ☞ BMI (kg/m2) = Weight (kg)/ {Height (m)}2 A person who has no clinically meaningful congenital or chronic disease and has no pathological symptoms or findings as a result of medical examination at a screening visit A person who has been determined to be suitable for the test as a result of diagnostic tests such as hematology tests, hematochemical tests, serum tests, urine tests, etc., set and conducted by the test manager (or delegated test doctor) according to the characteristics of clinical drugs A person who agrees to exclude the possibility of pregnancy using a medically recognized contraceptive method* (except hormones) and does not provide sperm or eggs from the date of first administration of the clinical trial drug to 14 days after the date of last clinical trial drug administration *medically-accepted Contraceptive methods: a combination of intrauterine devices, vasectomy, tubular ligation, and blocking contraception (male condoms, female condoms, cervical caps, contraceptive septum, sponge, etc.) or a combination of two or more blocking contraceptives A person who has received and understood sufficient explanation of the purpose, contents, characteristics of clinical trial drugs, expected abnormal cases, etc., and signed the consent form according to his/her free will Exclusion Criteria: A person who has or has a history of clinically significant diseases corresponding to the digestive system, cardiovascular system, endocrine system, respiratory system, blood and tumor, infectious disease, kidney and urinary system, mental and nervous system, musculoskeletal system A person who has a history of gastrointestinal surgery (excluding simple appendectomy or hernia surgery) or has gastrointestinal diseases that may affect drug absorption Those who have taken drug metabolism-inducing and inhibiting drugs such as barbital drugs within one month of the first administration date, or drugs that may interfere with this clinical trial within 10 days of the first administration (however, in consideration of pharmacokinetic and pharmacokinetic characteristics of combination drugs it may consider as possible) A person who participates in other clinical trials or biological equivalence tests within six months of the first administration and administered clinical trial drugs A person who has donated whole blood within 8 weeks of the first administration, donated ingredients within 2 weeks or received a blood transfusion within 4 weeks from the first administration A person who meets the following conditions within one month of the first dose date Men consume an average of 21 cups/week of alcohol Women consume an average of 14 cups/week of alcohol (1 glass = 50mL of soju, 30mL of spirits, or 250mL of beer) An average of more than 20 cigarettes a day A patient who falls under the following Patients with a history of hypersensitivity to the main ingredient or additive of this drug Type 1 diabetes patient with diabetic ketoacidosis Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption A patient on dialysis Patients with severe liver disorders, biliary obstruction, or bile congestion (mostly this drug is excreted as bile). A decrease in liver cleaning rate can be expected in patients with bile congestion, biliary obstruction disease, or liver failure.) Patients with hereditary angioedema, or patients with a history of angioedema when treated with ACE inhibitors or angiotensin II receptor antagonists Combination with aliskiren-containing preparations in patients with diabetes or moderate to severe renal disabilities (glomerular filtration rate <60mL/min/1.73m2) For reasons other than the above selection and exclusion criteria, the person in charge of testing (or the delegated test doctor) determines that he/she is not suitable for participation in this clinical trial In the case of female volunteers, those suspected of being pregnant or nursing
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaewoo Park
Phone
+82-70-8657-2278
Email
admin@thpharm.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung Hyun Kang, M.D
Organizational Affiliation
H Plus Yangji Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
H Plus Yangji Hospital
City
Seoul
ZIP/Postal Code
08779
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung Hyun Kang, Dr.
Phone
+82 70-4665-9490
Email
juspa@newyjh.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Clinical Trial to Evaluate the Safety and the Pharmacokinetic Interaction of Telmisartan and Dapagliflozin.

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