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

Yuhan

Status and phase: Completed; Phase 1

Conditions: Hypertension

Treatments: Drug: Chlorthalidone; Drug: Amlodipine; Drug: Telmisartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT02152969

YH22162-101

Details and patient eligibility

About

To evaluate Drug-drug interaction

Full description

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

Enrollment: 66 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Part B

Other group

Description:

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

Treatment:

Drug: Amlodipine

Drug: Telmisartan

Drug: Chlorthalidone

Part A

Other group

Description:

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

Treatment:

Drug: Amlodipine

Drug: Telmisartan

Drug: Chlorthalidone