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

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ClinicalTrials.gov Identifier: NCT02203500
Recruitment Status : Completed
First Posted : July 30, 2014
Last Update Posted : August 6, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Healthy Drug: Lacidipine Drug: Telmisartan Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : October 1998
Actual Primary Completion Date : January 1999

Resource links provided by the National Library of Medicine

Drug Information available for: Telmisartan

Arm Intervention/treatment
Experimental: Lacidipine Drug: Lacidipine
Experimental: Telmisartan Drug: Telmisartan
Experimental: Lacidipine + Telmisartan Drug: Lacidipine
Drug: Telmisartan



Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02203500    
Other Study ID Numbers: 1173.2
First Posted: July 30, 2014    Key Record Dates
Last Update Posted: August 6, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Telmisartan
Lacidipine
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs