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Trial record 20 of 71 for:    TELMISARTAN AND HYDROCHLOROTHIAZIDE

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

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ClinicalTrials.gov Identifier: NCT02183675
Recruitment Status : Completed
First Posted : July 8, 2014
Results First Posted : November 30, 2016
Last Update Posted : November 30, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief 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

Condition or disease Intervention/treatment Phase
Healthy Drug: Telmisartan/Amlodipine Drug: Telmisartan/Amlodipine/HCTZ Drug: Telmisartan/HCTZ Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : July 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

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Arm Intervention/treatment
Experimental: T/A/H
Telmisartan/Amlodipine/HCTZ fixed-dose combination
Drug: Telmisartan/Amlodipine/HCTZ
Telmisartan/Amlodipine/HCTZ fixed-dose combination

Active Comparator: T/A
Telmisartan/Amlodipine fixed-dose combination
Drug: Telmisartan/Amlodipine
Telmisartan/Amlodipine fixed-dose combination

Active Comparator: T/H
Telmisartan/HCTZ fixed-dose combination
Drug: Telmisartan/HCTZ
Telmisartan/HCTZ fixed-dose combination




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02183675


Locations
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Japan
1348.5.001 Boehringer Ingelheim Investigational Site
Kanagawa , Yokohama, Japan
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02183675     History of Changes
Other Study ID Numbers: 1348.5
First Posted: July 8, 2014    Key Record Dates
Results First Posted: November 30, 2016
Last Update Posted: November 30, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Hydrochlorothiazide
Telmisartan
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists