Status:
COMPLETED
Impact of Food on Pharmacokinetics and Pharmacodynamics of Asasantin ER in Healthy Subjects
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
Comparative pharmacokinetics and pharmacodynamics of Asasantin ER at fasted and fed state
Eligibility Criteria
Inclusion
- Healthy subjects as determined by results of screening
- Signed written informed consent in accordance with good clinical practice (GCP) and local legislation
- Age ≥ 18 and ≤ 55 years
- Broca ≥ - 20 % and ≤ + 20 %
Exclusion
- Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastro-intestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
- Chronic or relevant acute infections
- History of hypersensitivity to Asasantin ER and any of the excipients
- 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 (\< 1 month prior to administration or during the trial)
- Known alcohol abuse
- Known drug abuse
- Blood donation (\< 1 month prior to administration)
- Excessive physical activities (\< 5 days prior to administration)
- History of hemorrhagic diatheses
- History of gastro-intestinal ulcer, perforating or bleeding
- History of bronchial asthma
- Any laboratory value outside the normal range of clinical relevance
- Female subjects:
- Pregnancy
- Positive pregnancy test
- No adequate contraception (adequate contraception e.g. sterilization, intrauterine devices (IUD), oral contraceptives)
- Inability to maintain this adequate contraception during the whole study period
- Lactation period
Key Trial Info
Start Date :
August 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT02273492
Start Date
August 1 1999
Last Update
October 24 2014
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