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Telmisartan/Hydrochlorothiazide (HCTZ) Fixed Dose Combination Compared to Its Monocomponents in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02176512
Recruitment Status : Completed
First Posted : June 27, 2014
Last Update Posted : July 8, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study to demonstrate the bioequivalence of telmisartan and HCTZ administered as fixed dose combination in comparison to the single unit formulations

Condition or disease Intervention/treatment Phase
Healthy Drug: BIBR 277 SE and HCTZ Drug: BIBR 277 SE Drug: HCTZ Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Relative Oral Bioavailability of 80 mg Telmisartan / 12.5 mg HCTZ Fixed Dose Combination Compared With Its Monocomponents in Healthy Subjects. A 4 Period Cross-over, Open, Randomized, Replicate Design Study.
Study Start Date : September 1998
Actual Primary Completion Date : October 1998

Resource links provided by the National Library of Medicine

Drug Information available for: Telmisartan

Arm Intervention/treatment
Experimental: Sequence 1

four treatment periods:

  1. Treatment A
  2. Treatment B
  3. Treatment B
  4. Treatment A
Drug: BIBR 277 SE and HCTZ
Treatment A - fixed dose combination

Drug: BIBR 277 SE
Treatment B - Monocomponent

Drug: HCTZ
Treatment B -Monocomponent

Active Comparator: Sequence 2

four treatment periods:

  1. Treatment B
  2. Treatment A
  3. Treatment A
  4. Treatment B
Drug: BIBR 277 SE and HCTZ
Treatment A - fixed dose combination

Drug: BIBR 277 SE
Treatment B - Monocomponent

Drug: HCTZ
Treatment B -Monocomponent

Primary Outcome Measures :
  1. AUC0-∞ (total area under the plasma drug concentration-time curve from time zero to infinity) [ Time Frame: up to 96 hours post-dose ]
  2. Cmax (maximum drug plasma concentration) [ Time Frame: up to 96 hours post-dose ]
  3. Amount of Hydrochlorothiazide (HCTZ) excreted in urine over 48 hours (Ae(0-48h)) [ Time Frame: 0-6, 6-12, 12-24, 24-32, 32-48 hours post-dose ]

Secondary Outcome Measures :
  1. tmax (time to achieve Cmax) [ Time Frame: up to 96 hours post-dose ]
  2. t1/2 (apparent terminal elimination half-life) [ Time Frame: up to 96 hours post-dose ]
  3. CLtot/f (total clearance of a drug from plasma, divided by bioavailability) [ Time Frame: up to 96 hours post-dose ]
  4. MRTtot (mean time of residence of drug molecules in the body) [ Time Frame: up to 96 hours post-dose ]
  5. Vz/f (apparent volume of distribution during terminal phase) [ Time Frame: up to 96 hours post-dose ]
  6. Number of patients with adverse events [ Time Frame: Up to 62 days ]

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy subjects as determined by results of screening
  • Signed written informed consent in accordance with GCP (Good Clinical Practice) and local legislation
  • Age ≥ 18 and ≤ 45 years
  • Broca ≥ - 20% and ≤ + 20%

Exclusion Criteria:

  • Any findings of the medical examination (including blood pressure, pulse rate and ECG and laboratory value) deviating from normal and of clinical relevance
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Surgery of the gastro-intestinal tract (except appendectomy)
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
  • Supine blood pressure at screening of systolic ≤ 110 mmHg and diastolic ≤ 60 mmHg
  • History of orthostatic hypotension, fainting spells or blackouts
  • Hypersensitivity to Telmisartan and/or HCTZ and/or related classes of drugs
  • History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  • Use of any drugs which might influence the results of the trial (≤ 10 days prior to administration or during the trial)
  • Participation in another trial with an investigational drug (≤ 2 months prior to administration or during the trial)
  • Smoker (≥ 10 cigarettes or ≥ 3 cigars or ≥ 3 pipes/day)
  • Inability to refrain from smoking on study days
  • Known alcohol abuse
  • Known drug abuse
  • Blood donation (≤ 1 month prior to administration)
  • Excessive physical activities (≤ 5 days prior to administration)
  • For female subjects:

    • Pregnancy
    • Positive pregnancy test
    • No adequate contraception
    • Inability to maintain this adequate contraception during the whole study period
    • Lactation period

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Responsible Party: Boehringer Ingelheim Identifier: NCT02176512     History of Changes
Other Study ID Numbers: 502.136
First Posted: June 27, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators