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

Boehringer Ingelheim36 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Telmisartan/AmlodipineDRUG

Telmisartan/Amlodipine fixed-dose combination

Telmisartan/Amlodipine/HCTZDRUG

Telmisartan/Amlodipine/HCTZ fixed-dose combination

Telmisartan/HCTZDRUG

Telmisartan/HCTZ fixed-dose combination

Eligibility

Sex: MALEMin age: 20 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

1348.5.001 Boehringer Ingelheim Investigational Site

Kanagawa , Yokohama, Japan

Outcomes

Primary Outcomes

Maximum Measured Concentration (Cmax) at Steady State for Telmisartan

Maximum measured concentration (Cmax) of telmisartan in plasma at steady state over the dosing interval tau

Time frame: 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h and 72h after 10 days drug administration

Area Under the Plasma Concentration Curve at Steady State for Telmisartan

Area under the plasma concentration curve (AUC) of telmisartan in plasma at steady state over the dosing interval tau

Time frame: 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h and 72h after 10 days drug administration

Maximum Measured Concentration (Cmax) at Steady State for Amlodipine

Maximum measured concentration (Cmax) of amlodipine in plasma at steady state over the dosing interval tau

Time frame: 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h and 144h after 10 days drug administration

Area Under the Plasma Concentration Curve at Steady State for Amlodipine

Area under the plasma concentration curve (AUC) of amlodipine in plasma at steady state over the dosing interval tau

Maximum Measured Concentration (Cmax) at Steady State for HCTZ

Maximum measured concentration (Cmax) of HCTZ in plasma at steady state over the dosing interval tau

Time frame: 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h and 48h after 10 days drug administration

Data from ClinicalTrials.gov

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