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

NCT ID: NCT02152969

Last Updated: 2014-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-11-30

Brief Summary

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To evaluate Drug-drug interaction

Detailed Description

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

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Part B

Arm to evaluate influence of Chlorthalidone on pharmacokinetics of amlodipine and telmisartan.

Group Type OTHER

Telmisartan

Intervention Type DRUG

Amlodipine

Intervention Type DRUG

Chlorthalidone

Intervention Type DRUG

Part A

Arm to evaluate influence of amlodipine and telmisartan on pharmacokinetics of Chlorthalidone.

Group Type OTHER

Telmisartan

Intervention Type DRUG

Amlodipine

Intervention Type DRUG

Chlorthalidone

Intervention Type DRUG

Interventions

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Telmisartan

Intervention Type DRUG

Amlodipine

Intervention Type DRUG

Chlorthalidone

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yuhan Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dong Seok Yim

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea

Locations

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The Catholic University of Korea Seoul St.Mary's Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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YH22162-101

Identifier Type: -

Identifier Source: org_study_id