Working… Menu
Help guide our efforts to modernize
Send us your comments by March 14, 2020.

Relative Oral Bioavailability of Telmisartan / Hydrochlorothiazide (HCTZ) Fixed Dose Combination (FDC) Compared With 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: NCT02187523
Recruitment Status : Completed
First Posted : July 11, 2014
Last Update Posted : July 11, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
A 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: Hydrochlorothiazide Drug: Telmisartan Drug: Telmisartan/HCTZ FDC Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Relative Oral Bioavailability of 40 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 : October 1999
Actual Primary Completion Date : December 1999

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Telmisartan/HCTZ FDC Drug: Telmisartan/HCTZ FDC
Active Comparator: Telmisartan and HCTZ individual tablets Drug: Hydrochlorothiazide
Drug: Telmisartan

Primary Outcome Measures :
  1. Total area under concentration-time curve of the analytes in plasma from time zero to infinity (AUC0-∞) [ Time Frame: Pre-dose up to day 54 ]
  2. Maximum concentration of the analytes in plasma (Cmax) [ Time Frame: Pre-dose up to day 54 ]
  3. Amount of HCTZ excreted in urine over 48 h (Ae(0-48)) [ Time Frame: Pre-dose up to day 50 ]

Secondary Outcome Measures :
  1. time to achieve maximum concentration of the analytes in plasma (tmax) [ Time Frame: Pre-dose up to day 54 ]
  2. Terminal elimination half life of the analytes in plasma (t1/2) [ Time Frame: Pre-dose up to day 54 ]
  3. Total clearance of the of the analytes after oral administration (CLtot/f) [ Time Frame: Pre-dose up to day 54 ]
  4. Total mean residence time of the analytes (MRTtot) [ Time Frame: Pre-dose up to day 54 ]
  5. Apparent volume of distribution of the analytes during the terminal phase (Vz/f) [ Time Frame: Pre-dose up to day 54 ]
  6. Number of patients with relevant changes in laboratory values [ Time Frame: Screening (day -14 to day 0) and day 72 ]
  7. Number of patients with relevant changes in vital signs (blood pressure, pulse rate) [ Time Frame: Up to day 72 ]
  8. Number of patients with Adverse events [ Time Frame: Up to day 72 ]
  9. Number of patients with relevant changes in ECG [ Time Frame: Screening (day -14 to day 0) and day 72 ]
  10. Number of patients with relevant changes in physical examination [ Time Frame: Screening (day -14 to day 0) and day 72 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 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 good clinical practice (GCP) and local legislation
  • Age ≥ 18 and ≤ 55 years
  • Broca ≥ -20 % and ≤ +20 %

Exclusion Criteria:

  • Any findings of the medical examination (including blood pressure, pulse rate and electrocardiogram (ECG)) 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 or neurological disorders
  • Supine blood pressure at screening of systolic ≤ 110 mmHg and diastolic ≤ 60 mmHg
  • History of orthostatic hypotension, fainting, spells or blackouts
  • Chronic or relevant acute infection
  • History or allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  • Intake of drugs with a long half-life (> 24 hours) ≤ 1 month prior to administration or during the trial
  • 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
  • Alcohol abuse (> 60g/day)
  • Drug abuse
  • Blood donation (≤ 1 month prior to administration or during the trial)
  • Excessive physical activities (≤ 5 days prior to administration or during the trial)
  • Any laboratory value outside the reference range of clinical relevance
  • Hypersensitivity to Telmisartan and/or HCTZ and/or related classes of drugs

For female subjects:

  • Pregnancy
  • Positive pregnancy test
  • No adequate contraception (e.g. sterilization, intrauterine device (IUD), oral contraceptives)
  • Inability to maintain this adequate contraception during the whole study period
  • Lactation period

Layout table for additonal information
Responsible Party: Boehringer Ingelheim Identifier: NCT02187523    
Other Study ID Numbers: 502.324
First Posted: July 11, 2014    Key Record Dates
Last Update Posted: July 11, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Antihypertensive Agents
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists