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Completed

NCT Number: NCT02209649

Bioavailability of Lacidipine and Telmisartan Fixed Dose Combination Tablets Relative to Separate Tablets in Healthy Subjects

Study to compare the bioavailability of Lacidipine and Telmisartan administered as fixed dose combination tablets with the separate Telmisartan and Lacidipine tablets.

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Key information

Conditions

Healthy

Age range

18 year–50 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

  • Healthy male and female Caucasian subjects as determined by results of screening
  • Age ≥ 18 and ≤ 50 years
  • Broca ≥ - 20 % and ≤ + 20 %
  • Written informed consent in accordance with Good Clinical Practice and local legislation given

Exclusion criteria

  • Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Surgery of gastrointestinal tract (except appendectomy)
  • Disease of the central nervous system (such as epilepsy) or psychiatric disorders or neurologic disorders
  • History of orthostatic hypotension, fainting spells or blackouts
  • Chronic or relevant acute infections
  • History of 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, except for oral contraceptives)
  • Use of any drugs which might influence the results of the trial (≤ 10 days prior to administration or during the trial except for oral contraceptives)
  • 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 trial days
  • Alcohol abuse (> 60 g/day)
  • Blood donation > 100 ml (≤ 4 weeks prior to administration or during the trial)
  • Excessive physical activities (≤ 10 days prior to administration or during the trial)
  • Any laboratory value outside the reference range of clinical relevance
  • Females only:
  • no reliable contraception (e.g. oral contraceptives, 3-month injection, intrauterine device, sterilisation)
  • pregnancy of breast feeding period

Treatment and study plan

Lacidipine and Telmisartan fixed dose combination (FDC) tablet

Drug

Lacidipine

Drug

Telmisartan

Drug

Primary outcomes

  1. Area under the curve at steady state (AUCss)

    Time frame: up to 72 hours after drug administration at day 7

  2. Maximum concentration (Cmax,ss)

    Time frame: up to 72 hours after drug administration at day 7

  3. Time to maximum concentration (tmax)

    Time frame: up to 72 hours after drug administration at day 7

  4. Total apparent clearance (CLtot/f)

    Time frame: up to 72 hours after drug administration at day 7

  5. Apparent volume of distribution (Vz/f)

    Time frame: up to 72 hours after drug administration at day 7

  6. Mean residence time (MRTss)

    Time frame: up to 72 hours after drug administration at day 7

  7. Terminal half-life (t1/2)

    Time frame: up to 72 hours after drug administration at day 7

  8. Number of patients with adverse events

    Time frame: up to 66 days

  9. Number of patients with abnormal findings in physical examination

    Time frame: up to 66 days

  10. Number of patients with clinically relevant changes in electrocardiogram

    Time frame: up to 66 days

  11. Number of patients with clinically relevant changes in vital signs

    Time frame: up to 66 days

  12. Number of patients with abnormal changes in laboratory parameters

    Time frame: up to 66 days

  13. Assessment of tolerability on a verbal rating scale

    Time frame: between day 3 and 5 after last study drug administration

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Bioavailability of Lacidipine 4 mg and Telmisartan 40 mg Administered Orally as Two Experimental Fixed Dose Combination Tablets Relative to Separate Tablets. An Open Randomised Three-way Cross-over Steady State Trial in 6 Female and 6 Male Healthy Subjects

Important dates

Study start
1999
Primary completion
1999
First posted
Aug 6, 2014
Registry last updated
Aug 6, 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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