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

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2014

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

Arms, Groups and Cohorts

  • Experimental: T/A/H
    • Telmisartan/Amlodipine/HCTZ fixed-dose combination
  • Active Comparator: T/A
    • Telmisartan/Amlodipine fixed-dose combination
  • Active Comparator: T/H
    • Telmisartan/HCTZ fixed-dose combination

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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 Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: Male

Minimum Age: 20 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Boehringer Ingelheim
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Boehringer Ingelheim, Study Chair, Boehringer Ingelheim

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