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Study to Investigate the Effect of Atorvastatin on the Pharmacokinetic Properties of Telmisartan/S-amlodipine (CKD-345 DDI)

Primary Purpose

Essential Hypertension, Hyperlipidemia

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg
Telmisartan 80mg and S-amlodipine 5mg
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension focused on measuring Telminuvo, Telmisartan, S-amlodipine, Atorvastatin, pharmacokinetics, Healthy volunteers

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Between 20 aged and 45 aged in healthy male and female
  2. Body weight more than 55kg in male, 50kg in female
  3. Body Mass Index more than 18.5 and under 25 (Body Mass Index(kg/m2)= kg/(m)2) 4.If female, must include more than one among the items

    1. The menopause (there is no natural menses for at least 2 years)
    2. Surgical Infertility(hysterectomy or bilateral oophorectomy, tubal ligation or other methods of infertility condition)
    3. The male partner infertility before screening (Demonstrated azoospermia after vasectomy)and if this man is the only partner of the female subject.
    4. you are using one of the following contraceptive measure for 3 months before screening, and Necessarily you agree that used continuously contraceptive measure during the clinical trial and for 1 month after the final dosing investigational product.(But, should not use a device of contraception or oral contraceptive drug that containing a hormonal caused telmisartan, s-amlodipine, atorvastatin calcium drug interactions during the clinical trials)

      • Abstinence.
      • Physical interrupt method (such as a condom, contraceptive diaphoretic or cervical cap)
    5. In case of women of childbearing age, the serum β-hCG pregnancy test is negative, and urine β-hCG test is negative before taking the investigational product.

5.If men has sexual life with women of childbearing age, Necessarily he agrees that use condoms during clinical trials and do not sperm donation during clinical trials and until one month after the final dosage of investigational products 6.Those who fully understand about this clinical trial after enough hearing, and then decided to join the clinical trials by themselves and to comply with the precautions written consent.

Exclusion Criteria:

  1. Have clinically significant disease that hepatobiliary system(severe hepatic impairment, etc), kidney(severe renal impairment, etc.), nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system (heart failure, etc.).or mental illness, or a history of mental disease.
  2. Have a gastrointestinal disease history that can affect drug absorption (Crohn's disease, ulcers, etc.) or surgery (except simple appendectomy or hernia surgery)
  3. hypersensitivity reaction to drug or clinically significant hypersensitivity reaction in the history of Investigational drugs (telmisartan, s-amlodipine or atorvastatin calcium) or additives.
  4. An impossible one who participates in clinical trial including screening tests(medical history taking, BP, physical examination, 12-lead ECG, blood & urine laboratory test result) before 28 days the taking Investigational Products.
  5. Defined by the following laboratory parameters:

    1. AST, ALT> 1.25* upper limit of normal range
    2. Total bilirubin > 1.5* upper limit of normal range
    3. CPK > 1.5* upper limit of normal range
    4. eGFR(using by MDRD method) < 60 mL/min/1.73m2
  6. Sitting SBP > 150 mmHg or < 90 mmHg, Sitting DBP> 100 mmHg or < 50 mmHg , after 5minuts break.
  7. Drug abuse or have a history of drug abuse showed a positive for urine drug test.
  8. Pregnant or lactating women.
  9. A heavy caffeine consumer(caffeine>5cups/day), alcohol consumer(alcohol>210g/week), or smoker(cigarette>10cigarettes/day)
  10. Subject takes ethical drug or herbal medicine within 14days, OTC within 7days before the beginning of study treatment but investigator determine that the taking drug affect this study or could affect the safety of the subjects.
  11. Subject who takes inhibitors and inducers of drug metabolizing enzyme(Barbiturates etc.) within 30 days.
  12. Taking foods containing grapefruit within 7 days before the beginning of study treatment(ex. Drinking containing grapefruit of 1L per a day or more within 7 days before the beginning of study treatment)
  13. Subject who treated with any investigational drugs within 60days before the beginning of study treatment (However, biologicals applies for 90 days, but can be based on a more extended period of time by considering the half-life)
  14. Previously donate whole blood within 60 days or component blood within 30days.
  15. An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.
  16. Positive for Serology test(Hepatitis B, Hepatitis C, HIV).

Sites / Locations

  • Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg

Telmisartan 80mg and S-amlodipine 5mg

Arm Description

Outcomes

Primary Outcome Measures

In the steady state Telmisartan 80mg and S-amlodipine 5mg AUClast
AUClast = Area under the plasma concentration-time curve from zero time until the last measurable concentration
In the steady state Telmisartan 80mg and S-amlodipine 5mg Cmax
Cmax=Maximum Plasma Drug Concentration

Secondary Outcome Measures

In the steady state Telmisartan 80mg & S-amlodipine 5mg AUCinf
AUCinf=Area under the plasma concentration-time curve from time zero to infinity
In the steady state Telmisartan 80mg & S-amlodipine 5mg Tmax
Tmax=Time to Cmax
In the steady state Telmisartan 80mg & S-amlodipine 5mg T1/2
T1/2=Observed terminal elimination half-life
Number of Participants with Adverse Events
Evaluated safety parameters included: Physical examination, vital sign, Laboratory test, ECG Adverse event monitoring

Full Information

First Posted
April 25, 2013
Last Updated
July 31, 2013
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT01842230
Brief Title
Study to Investigate the Effect of Atorvastatin on the Pharmacokinetic Properties of Telmisartan/S-amlodipine
Acronym
CKD-345 DDI
Official Title
A Randomized, Open-label, Single Dose, Two-treatment, Two-period, Two-sequence Crossover Study to Investigate the Effect of Atorvastatin on the Pharmacokinetic Properties of Telmisartan/S-amlodipine After Oral Administration in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate the effect of Atorvastatin on the pharmacokinetic properties of Telmisartan/S-amlodipine

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension, Hyperlipidemia
Keywords
Telminuvo, Telmisartan, S-amlodipine, Atorvastatin, pharmacokinetics, Healthy volunteers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg
Arm Type
Experimental
Arm Title
Telmisartan 80mg and S-amlodipine 5mg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg
Intervention Description
Telmisartan 80mg, S-amlodipine 5mg: 1 tablet, oral, once daily, 1day Atorvastatin 40mg: 1 tablet, oral, once daily, 2days over the period I & II(cross-over)
Intervention Type
Drug
Intervention Name(s)
Telmisartan 80mg and S-amlodipine 5mg
Intervention Description
Telmisartan 80mg, S-amlodipine 5mg: 1 tablet, oral, once daily, 1day over the period I & II(cross-over)
Primary Outcome Measure Information:
Title
In the steady state Telmisartan 80mg and S-amlodipine 5mg AUClast
Description
AUClast = Area under the plasma concentration-time curve from zero time until the last measurable concentration
Time Frame
Telmisartan: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 36, 48hr post-dose, S-amlodipine:Pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168hr post-dose
Title
In the steady state Telmisartan 80mg and S-amlodipine 5mg Cmax
Description
Cmax=Maximum Plasma Drug Concentration
Time Frame
Telmisartan: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 36, 48hr post-dose, S-amlodipine: Pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168hr post-dose
Secondary Outcome Measure Information:
Title
In the steady state Telmisartan 80mg & S-amlodipine 5mg AUCinf
Description
AUCinf=Area under the plasma concentration-time curve from time zero to infinity
Time Frame
Telmisartan: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 36, 48hr post-dose, S-amlodipine:Pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168hr post-dose
Title
In the steady state Telmisartan 80mg & S-amlodipine 5mg Tmax
Description
Tmax=Time to Cmax
Time Frame
Telmisartan: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 36, 48hr post-dose, S-amlodipine:Pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168hr post-dose
Title
In the steady state Telmisartan 80mg & S-amlodipine 5mg T1/2
Description
T1/2=Observed terminal elimination half-life
Time Frame
Telmisartan: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 36, 48hr post-dose, S-amlodipine:Pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168hr post-dose
Title
Number of Participants with Adverse Events
Description
Evaluated safety parameters included: Physical examination, vital sign, Laboratory test, ECG Adverse event monitoring
Time Frame
From 1day to 22 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Between 20 aged and 45 aged in healthy male and female Body weight more than 55kg in male, 50kg in female Body Mass Index more than 18.5 and under 25 (Body Mass Index(kg/m2)= kg/(m)2) 4.If female, must include more than one among the items The menopause (there is no natural menses for at least 2 years) Surgical Infertility(hysterectomy or bilateral oophorectomy, tubal ligation or other methods of infertility condition) The male partner infertility before screening (Demonstrated azoospermia after vasectomy)and if this man is the only partner of the female subject. you are using one of the following contraceptive measure for 3 months before screening, and Necessarily you agree that used continuously contraceptive measure during the clinical trial and for 1 month after the final dosing investigational product.(But, should not use a device of contraception or oral contraceptive drug that containing a hormonal caused telmisartan, s-amlodipine, atorvastatin calcium drug interactions during the clinical trials) Abstinence. Physical interrupt method (such as a condom, contraceptive diaphoretic or cervical cap) In case of women of childbearing age, the serum β-hCG pregnancy test is negative, and urine β-hCG test is negative before taking the investigational product. 5.If men has sexual life with women of childbearing age, Necessarily he agrees that use condoms during clinical trials and do not sperm donation during clinical trials and until one month after the final dosage of investigational products 6.Those who fully understand about this clinical trial after enough hearing, and then decided to join the clinical trials by themselves and to comply with the precautions written consent. Exclusion Criteria: Have clinically significant disease that hepatobiliary system(severe hepatic impairment, etc), kidney(severe renal impairment, etc.), nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system (heart failure, etc.).or mental illness, or a history of mental disease. Have a gastrointestinal disease history that can affect drug absorption (Crohn's disease, ulcers, etc.) or surgery (except simple appendectomy or hernia surgery) hypersensitivity reaction to drug or clinically significant hypersensitivity reaction in the history of Investigational drugs (telmisartan, s-amlodipine or atorvastatin calcium) or additives. An impossible one who participates in clinical trial including screening tests(medical history taking, BP, physical examination, 12-lead ECG, blood & urine laboratory test result) before 28 days the taking Investigational Products. Defined by the following laboratory parameters: AST, ALT> 1.25* upper limit of normal range Total bilirubin > 1.5* upper limit of normal range CPK > 1.5* upper limit of normal range eGFR(using by MDRD method) < 60 mL/min/1.73m2 Sitting SBP > 150 mmHg or < 90 mmHg, Sitting DBP> 100 mmHg or < 50 mmHg , after 5minuts break. Drug abuse or have a history of drug abuse showed a positive for urine drug test. Pregnant or lactating women. A heavy caffeine consumer(caffeine>5cups/day), alcohol consumer(alcohol>210g/week), or smoker(cigarette>10cigarettes/day) Subject takes ethical drug or herbal medicine within 14days, OTC within 7days before the beginning of study treatment but investigator determine that the taking drug affect this study or could affect the safety of the subjects. Subject who takes inhibitors and inducers of drug metabolizing enzyme(Barbiturates etc.) within 30 days. Taking foods containing grapefruit within 7 days before the beginning of study treatment(ex. Drinking containing grapefruit of 1L per a day or more within 7 days before the beginning of study treatment) Subject who treated with any investigational drugs within 60days before the beginning of study treatment (However, biologicals applies for 90 days, but can be based on a more extended period of time by considering the half-life) Previously donate whole blood within 60 days or component blood within 30days. An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason. Positive for Serology test(Hepatitis B, Hepatitis C, HIV).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Soo Park, Ph. D
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Study to Investigate the Effect of Atorvastatin on the Pharmacokinetic Properties of Telmisartan/S-amlodipine

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