Status:
COMPLETED
Bioavailability of Lacidipine and Telmisartan Fixed Dose Combination Tablets Relative to Separate Tablets in Healthy Subjects
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
Study to compare the bioavailability of Lacidipine and Telmisartan administered as fixed dose combination tablets with the separate Telmisartan and Lacidipine tablets.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02209649
Start Date
October 1 1999
Last Update
August 6 2014
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