Status:
COMPLETED
Safety, Tolerability and Pharmacokinetics of Oral BIBP 5371 CL in Healthy Male and Female Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
21-50 years
Phase:
PHASE1
Brief Summary
Safety, tolerability and pharmacokinetics (including comparisons of different formulations and investigation of food effect)
Eligibility Criteria
Inclusion
- Healthy male and female volunteers
- Age 21 - 50 years
- Body mass index (BMI) 18.5 - 29.9 kg/m2
Exclusion
- Any finding of the medical examination (including blood pressure, pulse rate, respiratory rate, body temperature and ECG) deviating from normal
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system or psychiatric disorders or neurological disorders
- History of relevant 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) within at least 1 month or less than 10 half-lives of the respective drug before enrolment in the study
- Use of any drugs which might influence the results of the trial (within 1 week prior to administration or during the trial)
- Participation in another trial with an investigational drug (within 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 grams/day)
- Drug abuse
- Blood donation (≥ 100 mL within 4 weeks prior to administration or during the trial)
- Excessive physical activities (within the last week before the study)
- Any laboratory value outside the reference range of clinical relevance
- In addition, for female subjects:
- Pregnancy
- Positive pregnancy test
- No adequate contraception e.g. oral contraceptives, intrauterine device, sterilisation
- Females, who are not surgically sterile will be asked to additionally use barrier contraception methods (e.g. condoms) prior to administration of study medication, during the study and at least 1 month after release from the study
- Inability to maintain this adequate contraception during the whole study period
- Lactation period
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT02256709
Start Date
April 1 2004
Last Update
October 6 2014
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