Back to resultsThe PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine and JLP-1401 in Healthy Adult Volunteers Volunteers
Primary Purpose
Hypertension With Dyslipidemia
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
JLP-1401
Telmisartan/Amlodipine, Rosuvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension With Dyslipidemia
Eligibility Criteria
Inclusion Criteria:
- Healthy male volunteer, age is over 19 years Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 17.5 kg/m2 , no more than 30.5 kg/m2
- Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
- Subject who has the ability and willingness to participate the whole period of trial
Exclusion Criteria:
- Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
- Subjects who are allergic to investigational drug.
- Subjects who have a medical history which can affect the clinical trial.
- SBP < 90 mmHG, SBP > 140mmHG or DBP < 60 mmHG, DBP > 100mmHg
- AST or ALT > X 2 UNL
- CK > X 2 UNL
- History of drug abuse or positive drug screening.
- Participation in other drug studies within 3 months prior to the drug administration.
- Whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days.
Sites / Locations
- Chonbuk National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group I (JLP-1401)
Group II (Telmisartan/Amlodipine, Rosuvastatin)
Arm Description
JLP-1401(Telmisartan 80 mg, amlodipine 5 mg, rosuvastatin 5 mg)
Twinsta(Telmisartan 80 mg, amlodipine 5 mg) and Crestor(rosuvastatin 5 mg)
Outcomes
Primary Outcome Measures
AUCt
Area under the curve of telmisartan, amlodipine, rosuvastatin at 72 hours after baseline
Cmax
Peak concentration of telmisartan, amlodipine, rosuvastatin at 72 hours after baseline
Secondary Outcome Measures
Full Information
NCT ID
NCT03707899
First Posted
October 14, 2018
Last Updated
August 27, 2019
Sponsor
Jeil Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03707899
Brief Title
The PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine and JLP-1401 in Healthy Adult Volunteers Volunteers
Official Title
An Open Label, Randomized, Single-dose, 4-period Cross-over Study to Compare the Pharmacokinetics and Safety Following Administration of JLP-1401 and Co-administration of Telmisartan/Amlodipine and Rosuvastatin in Healthy Adult Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
December 13, 2018 (Actual)
Primary Completion Date
February 18, 2019 (Actual)
Study Completion Date
May 22, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jeil Pharmaceutical Co., Ltd.
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 PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine and JLP-1401 in Healthy Adult Volunteers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension With Dyslipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I (JLP-1401)
Arm Type
Experimental
Arm Description
JLP-1401(Telmisartan 80 mg, amlodipine 5 mg, rosuvastatin 5 mg)
Arm Title
Group II (Telmisartan/Amlodipine, Rosuvastatin)
Arm Type
Active Comparator
Arm Description
Twinsta(Telmisartan 80 mg, amlodipine 5 mg) and Crestor(rosuvastatin 5 mg)
Intervention Type
Drug
Intervention Name(s)
JLP-1401
Intervention Description
Administration of JLP-1401(Telmisartan/Amlodipine/Rosuvastatin)
Intervention Type
Drug
Intervention Name(s)
Telmisartan/Amlodipine, Rosuvastatin
Intervention Description
Administration of Temlisartan/Amlosipine(Twinsta®) and Rosuvastatin(Crestor®)
Primary Outcome Measure Information:
Title
AUCt
Description
Area under the curve of telmisartan, amlodipine, rosuvastatin at 72 hours after baseline
Time Frame
72 hr after baseline
Title
Cmax
Description
Peak concentration of telmisartan, amlodipine, rosuvastatin at 72 hours after baseline
Time Frame
72 hr after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male volunteer, age is over 19 years Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 17.5 kg/m2 , no more than 30.5 kg/m2
Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
Subject who has the ability and willingness to participate the whole period of trial
Exclusion Criteria:
Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
Subjects who are allergic to investigational drug.
Subjects who have a medical history which can affect the clinical trial.
SBP < 90 mmHG, SBP > 140mmHG or DBP < 60 mmHG, DBP > 100mmHg
AST or ALT > X 2 UNL
CK > X 2 UNL
History of drug abuse or positive drug screening.
Participation in other drug studies within 3 months prior to the drug administration.
Whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days.
Facility Information:
Facility Name
Chonbuk National University Hospital
City
Jeonju
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine and JLP-1401 in Healthy Adult Volunteers Volunteers
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