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Completed

NCT Number: NCT02203500

Tolerability and Pharmacokinetics of Lacidipine With and Without the Co-administration of Telmisartan in Female and Male Healthy Subjects

The objectives of this study are to compare the steady state pharmacokinetics of lacidipine with and without the co-administration of telmisartan and to compare the steady state pharmacokinetics of telmisartan with and without the co-administration of lacidipine

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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
  • Written informed consent in accordance with Good Clinical Practice and local legislation given
  • Age >= 18 and <= 50 years
  • Broca >= -20% and <= + 20%

Exclusion criteria

  • Any finding 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 gastrointestinal tract (except appendectomy)
  • Diseases 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)
  • 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 > 100 ml (<= 4 weeks prior to administration or during the trial)
  • Any laboratory value outside the reference range of clinical relevance
  • Female only:
  • no reliable contraception (reliable are: oral contraceptives, 3-month injection, Intrauterine devices (IUD), sterilization)
  • Pregnancy or breast feeding period

Treatment and study plan

Lacidipine

Drug

Telmisartan

Drug

Primary outcomes

  1. Number of subjects with clinically significant changes in vital signs

    Time frame: up to 12 days after last drug administration

  2. Number of subjects with abnormal changes in laboratory parameters

    Time frame: up to 12 days after last drug administration

  3. Cmax (Maximum measured concentration of the analyte in plasma)

    Time frame: up to 72 hours after drug administration

  4. Cmin (Minimum measured concentration of the analyte in plasma)

    Time frame: up to 72 hours after drug administration

  5. AUCss (Area under the concentration-time curve of the analyte in plasma at steady state)

    Time frame: up to 72 hours after drug administration

  6. tmax (Time from dosing to the maximum concentration of the analyte in plasma)

    Time frame: up to 72 hours after drug administration

  7. CL/F (Apparent clearance of the analyte in plasma following extravascular administration) )

    Time frame: up to 72 hours after drug administration

  8. Vz/F (Apparent volume of distribution of the analyte during the terminal phase)

    Time frame: up to 72 hours after drug administration

  9. t½ (Terminal half-life of the analyte in plasma)

    Time frame: up to 72 hours after drug administration

  10. MRT (Mean residence time of the analyte in the body)

    Time frame: up to 72 hours after drug administration

  11. Number of subjects with adverse events

    Time frame: up to 66 days

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Tolerability and Pharmacokinetics of 80 mg Telmisartan and 6 mg Lacidipine Alone and in Combination After 7 Days Treatment. An Open Randomised Three-way Cross-over Trial in Female and Male Healthy Subjects

Important dates

Study start
1998
Primary completion
1999
First posted
Jul 30, 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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