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

NCT02183675 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2016-11-30

Study results available
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Summary

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

Conditions

  • Healthy

Interventions

DRUG

Telmisartan/Amlodipine

Telmisartan/Amlodipine fixed-dose combination

DRUG

Telmisartan/Amlodipine/HCTZ

Telmisartan/Amlodipine/HCTZ fixed-dose combination

DRUG

Telmisartan/HCTZ

Telmisartan/HCTZ fixed-dose combination

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • Japan

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02183675 on ClinicalTrials.gov