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Bioequivalence Study of Telmisartan Between T80/A5/H12.5 mg FDC Tablet and T80/A5 mg Tab and H12.5 mg Tab Concomitant Use

NCT02121535 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2017-04-12

Study results available
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Summary

The study will be performed as an open-label, randomised, single-dose, two-sequence, four-period replicated crossover design. A total of 72 Japanese healthy male subjects will be randomised to 2 groups. The subjects are administrated either T80/A5/H12.5 mg FDC tablet once or T80/A5 mg FDC tablet and hydrochlorothiazide (HCTZ) 12.5 mg tablet once in each period. The length of admission will be 7 days in each period.

Conditions

  • Healthy

Interventions

DRUG

T80/A5 mg FDC tablet

DRUG

T80/A5 mg FDC tablet

A Telmisartan 80 mg/ Amlodipine 5 mg FDC tablet

DRUG

H12.5 mg tablet

DRUG

T80/A5/H12.5 ng FDC tablet

A Telmisartan 80 mg/Amlodipine 5 mg/HCTZ 12.5 mg FDC tablet

DRUG

H12.5 mf tablet

A HCTZ 12.5 mg tablet

DRUG

T80/A5/H12.5 mg FDC tablet

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
2014-04-30
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • Japan

More Related Trials

Entities

Companies

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 NCT02121535 on ClinicalTrials.gov