Skip to main content
OpenTrials
Completed

NCT Number: NCT02183675

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

20 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

1348.5.001 Boehringer Ingelheim Investigational Site

Kanagawa , Yokohama, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telmisartan/Amlodipine

Drug

Telmisartan/Amlodipine fixed-dose combination

Telmisartan/Amlodipine/HCTZ

Drug

Telmisartan/Amlodipine/HCTZ fixed-dose combination

Telmisartan/HCTZ

Drug

Telmisartan/HCTZ fixed-dose combination

Primary outcomes

  1. Maximum Measured Concentration (Cmax) at Steady State for Telmisartan

    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) of telmisartan in plasma at steady state over the dosing interval tau

  2. Area Under the Plasma Concentration Curve at Steady State for Telmisartan

    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 (AUC) of telmisartan in plasma at steady state over the dosing interval tau

  3. Maximum Measured Concentration (Cmax) at Steady State for Amlodipine

    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

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

  4. Area Under the Plasma Concentration Curve at Steady State for Amlodipine

    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 (AUC) of amlodipine in plasma at steady state over the dosing interval tau

  5. Maximum Measured Concentration (Cmax) at Steady State for HCTZ

    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

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

  6. Area Under the Plasma Concentration Curve at Steady State for HCTZ

    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

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

Secondary outcomes

  1. Amount of HCTZ Excreted in Urine at Steady State From 0 to 24 Hours

    Time frame: 0-6 hours (h), 6-12h and 12-24h after drug administration on day 10

    Amount of HCTZ excreted in urine over the time interval from 0 to 24 hours at steady state

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Pharmacokinetics of Multiple Oral Doses of Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg Fixed-dose Combination Tablet, Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg Fixed-dose Combination Tablet and Telmisartan 80 mg/Amlodipine 5 mg Fixed-dose Combination Tablet at Steady State in Healthy Male Subjects: an Open-label, Randomised, Multiple-dose, Three Treatment, Three-period, Six-sequence Crossover Study

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 8, 2014
Registry last updated
Nov 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.