Status:
COMPLETED
Tolerability and Pharmacokinetics of Lacidipine With and Without the Co-administration of Telmisartan in Female and Male Healthy Subjects
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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 te...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT02203500
Start Date
October 1 1998
Last Update
August 6 2014
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