Drug-drug Interaction Study (Telmisartan, Amlodipine, Chlorthalidone)

Phase 1

Completed

• Conditions: Hypertension
• Interventions: Drug: Telmisartan; Drug: Amlodipine; Drug: Chlorthalidone

• Registration Number: NCT02152969
• Lead Sponsor: Yuhan Corporation

Brief Summary

To evaluate Drug-drug interaction

Detailed Description

The purpose of this study is to evaluate the Drug-Drug(telmisartan, amlodipine and/ or chlorthalidone) interaction and safety in healthy adult volunteers.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-29
• Study First Submitted QC: 2014-05-29
• Study First Posted: 2014-06-02
• Primary Completion: 2014-08
• Status Verified: 2014-11
• Study Completion: 2014-11
• Last Update Submitted: 2014-11-18
• Last Update Posted: 2014-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

1. Participant who has a body weight that is ≥55kg(male) or ≥50kg(female) with ideal body weight of 80-120% (ideal body weight)
2. Who has not suffered from clinically significant disease
3. Provision of signed written informed consent

Exclusion Criteria

1. History of and clinically significant disease psychiatric, or malignancy.
2. A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs.
3. Administration of other investigational products within 3 months prior to the first dosing.
4. Administration of herbal medicine within 2 weeks or administration of ethical drugs within 2 weeks or administration of over-the-counter (OTC) drugs within 1 week prior to the first dosing of the investigational product (if the investigator (study doctor) determines that the person meets other criteria appropriately, the relevant person may participate in the study).
5. Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part B	Amlodipine	Arm to evaluate influence of Chlorthalidone on pharmacokinetics of amlodipine and telmisartan.
Part B	Telmisartan	Arm to evaluate influence of Chlorthalidone on pharmacokinetics of amlodipine and telmisartan.
Part B	Chlorthalidone	Arm to evaluate influence of Chlorthalidone on pharmacokinetics of amlodipine and telmisartan.
Part A	Telmisartan	Arm to evaluate influence of amlodipine and telmisartan on pharmacokinetics of Chlorthalidone.
Part A	Amlodipine	Arm to evaluate influence of amlodipine and telmisartan on pharmacokinetics of Chlorthalidone.
Part A	Chlorthalidone	Arm to evaluate influence of amlodipine and telmisartan on pharmacokinetics of Chlorthalidone.

Primary Outcome Measures

Name	Time	Method
AUCt ss, Cmax ss of telmisartan/amlodipine/chlorthalidone	Totally 28points for 24 hours

Secondary Outcome Measures

Name	Time	Method
Cmin ss, tmax ss, t1/2 of telmisartan/amlodipine/chlorthalidone	Totally 28points for 24 hours

Trial Locations

Locations (1)

The Catholic University of Korea Seoul St.Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of