Status:
COMPLETED
Influence of Pantoprazole on the Pharmacokinetics of Fradafiban After Multiple Oral Doses of Lefradafiban Over 5 Days in Healthy Subjects
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
18-60 years
Phase:
PHASE1
Brief Summary
To assess the absorption of 30 mg Lefradafiban in two formulations, each under physiological conditions and with 40 mg Pantoprazole
Eligibility Criteria
Inclusion
- Healthy male subjects as determined by results of screening
- Signed written informed consent in accordance with good clinical practice (GCP) and local legislation
- Age ≥ 18 and ≤ 60 years, planned stratification: age \< 40 years (4 subjects) and ≥ 40 years (8 subjects)
- Broca ≥ - 20 % and ≤ + 20 %
Exclusion
- Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial
- Intake of drugs with a long half-life (\> 24 hours) within 1 month prior to administration
- Participation in another trial with an investigational drug within 2 months prior to administration or during the trial
- Drug abuse
- Alcohol abuse (\> 60 g/day)
- Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
- Excessive physical activities within 5 days prior to administration or during the trial
- Blood donation within 1 month prior to administration or during the trial
- History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hormonal disorders
- Chronic or relevant acute infections
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
- History of
- Allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Any bleeding disorder including prolonged or habitual bleeding
- Other hematologic disease
- Cerebral bleeding (e.g. after a car accident
- Recent surgical procedures
- Thrombocytes \< 150000/µ
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- Any laboratory value outside the clinically accepted reference range
- Other disease or abnormality of clinical relevance
Key Trial Info
Start Date :
April 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02264106
Start Date
April 1 1998
Last Update
October 15 2014
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