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Completed

NCT Number: NCT02262559

Bioequivalence of BIBR 277 Tablet Compared With Capsule in Healthy Male Volunteers

Study to investigate the bioequivalence of BIBR 277 tablet (Erythritol based) vs. BIBR 277 capsule

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Key information

Conditions

Age range

20 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age >= 20 and <= 35 years
  • Weight: BMI >= 17.6 and <= 26.4 (Weight (kg) / Height (m)2)
  • Subjects judged by the investigator to be eligible as study subjects, with no clinically significant findings after screening
  • Subjects who volunteer to participate and are able to fully understand and agree with this study by written informed consent

Exclusion criteria

  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  • Chronic or relevant acute infections
  • History of hepatic disorder (e.g., biliary cirrhosis, cholestasis)
  • History of serious renal disorder
  • History of or present bilateral renal artery stenosis or lack of unilateral kidney accompanying arterial stenosis
  • History of or present cerebrovascular disorder
  • History of hyperkalemia
  • History of hypersensitivity to active ingredient (Telmisartan) or other angiotensin II receptor antagonists
  • History of or present orthostatic hypotension or faint
  • Surgery of gastrointestinal tract (except appendectomy)
  • History of alcohol or drug abuse
  • Participation to another trial with an investigational drug within 4 months prior to the trial
  • Whole blood donation more than 400 mL within 3 months prior to the trial
  • Whole blood donation more than 100 mL within 1 month prior to the trial
  • Donation of constituent of blood of more than 400 mL within 1 month prior to the trial
  • Any medication which might influence the result of the trial within 10 days prior to the trial
  • Excessive physical activities within 7 days prior to the trial
  • Alcohol drinking within 3 days prior to the trial
  • Inability to comply with restriction of protocol
  • Other than above, those who are judged by the investigator to be inappropriate as the subjects of the study

Treatment and study plan

BIBR 277 tablet

Drug

Other names: Telmisartan

BIBR 277 capsule

Drug

Other names: Telmisartan

Primary outcomes

  1. Cmax (maximum observed concentration of the Telmisartan in plasma)

    Time frame: up to 72 hours after drug administration

  2. AUC0-72hr (area under the concentration-time curve of the Telmisartan in plasma from zero time to 72hr

    Time frame: up to 72 hours after drug administration

Secondary outcomes

  1. Individual time courses of the Telmisartan plasma concentrations

    Time frame: up to 72 hours after drug administration

  2. tmax (time to reach Cmax)

    Time frame: up to 72 hours after drug administration

  3. t1/2 (terminal half-life of the Telmisartan in plasma)

    Time frame: up to 72 hours after drug administration

  4. AUC0-∞(area under the concentration-time curve of Telmisartan in plasma from zero time to infinity)

    Time frame: up to 72 hours after drug administration

  5. MRT0-∞ (total mean residence time of Telmisartan molecules in the body)

    Time frame: up to 72 hours after drug administration

  6. Number of subjects with adverse events

    Time frame: up to 72 hours after last drug administration

  7. Number of subjects with clinically significant findings in vital signs

    Time frame: up to 72 hours after last drug administration

    blood pressure, pulse rate

  8. Number of subjects with clinically significant findings in laboratory tests

    Time frame: up to 72 hours after last drug administration

  9. Number of subjects with clinically significant findings in ECG

    Time frame: up to 72 hours after last drug administration

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Bioequivalence Study of BIBR 277 Tablet (Erythritol Based) Compared With Its Capsule Formation in Healthy Male Volunteers

Important dates

Study start
2002
Primary completion
2002
First posted
Oct 13, 2014
Registry last updated
Oct 13, 2014

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.

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