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

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Amlodipine; Hydrochlorothiazide; Telmisartan; Telmisartan amlodipine combination

Criteria

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.