Pharmacokinetics of Different Formulations of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ) in Japanese Healthy Male Volunteers

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Telmisartan/Amlodipine/HCTZ; Drug: Telmisartan/HCTZ; Drug: Telmisartan/Amlodipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02183675

1348.5

Details and patient eligibility

About

To assess drug drug interaction through pharmacokinetics investigation at steady state of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ) given as three different formulations in healthy Japanese male subjects

Enrollment: 36 patients

Sex: Male

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Japanese male subjects age >=20 and <=35 years; body weight: >=50 kg and <=80 kg; body mass index: >=18.0 and <=25.0 kg/m2
• Without any clinically significant findings and complications on the basis of a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature), 12-lead electrocardiograms (ECGs), clinical laboratory tests
• Signed and dated written informed consent prior to admission to the trial in accordance with the Good Clinical Practice (GCP) and the local legislation.

Exclusion criteria

• Any finding of the medical examination (including BP, PR and ECGs) deviating from normal and of clinical relevance.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

T/A/H

Experimental group

Description:

Telmisartan/Amlodipine/HCTZ fixed-dose combination

Treatment:

Drug: Telmisartan/Amlodipine/HCTZ

T/A

Active Comparator group

Description:

Telmisartan/Amlodipine fixed-dose combination

Treatment:

Drug: Telmisartan/Amlodipine

T/H

Active Comparator group

Description:

Telmisartan/HCTZ fixed-dose combination

Treatment:

Drug: Telmisartan/HCTZ