Status:
COMPLETED
Study to Compare the Pharmacokinetics of Dipyridamole in Three Different Asasantin Extended Release (ER) Formulations in Healthy Male and Female Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
21-50 years
Phase:
PHASE1
Brief Summary
Comparative pharmacokinetics of dipyridamole in two new formulations of Asasantin ER compared to the present commercial formulation
Eligibility Criteria
Inclusion
- All participants in the study should be healthy males or females, range from 21 to 50 years of age and be within ± 20 % of their normal weight (Broca-Index)
- Prior to admission to the study all volunteers will have given, in accordance with good clinical practice (GCP) and the local legislation, their written informed consent
- Subsequently each subject will have his medical history taken and will receive a complete medical examination (incl. blood pressure and pulse rate measurements) as well as a 12-lead ECG
- Hematopoietic, hepatic and renal function tests will be carried out in the laboratory
- The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations
- The above mentioned examinations will be performed within 14 days before the first administration of the test substance
Exclusion
- Volunteers are excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
- Subjects with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Subjects with diseases of the central nervous system (such as epilepsy) or with psychiatric or neurological disorders
- History of orthostatic hypotension, fainting spells or blackouts
- Subjects with chronic or relevant acute infections
- Subjects with allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Volunteers who have taken a drug with a long half-life (≥ 24 hours) within one month or less than ten half-lives of the respective drug before enrolment in the study
- Volunteers who receive any other drugs which might influence the results of the trial during the week previous to enrolment in the study
- Volunteers who participate in another study with an investigational drug within the last two months preceding the study
- Volunteers who are unable to refrain from smoking on study days
- Volunteers who smoke more than10 cigarettes (or equivalent) per day
- Volunteers who drink more than 60 g of alcohol per day
- Volunteers who are dependent on drugs
- Volunteers who donate blood (≥ 100 mL) within the last four weeks
- Volunteers who participate in excessive physical activities within the last week before the study (e.g. competitive sports)
- Volunteers who suffer from any other disease or abnormality of clinical relevance
- History of hemorrhagic diatheses
- History of gastro-intestinal ulcer, perforation or bleeding
- History of bronchial asthma
- History of glucose-6-phosphate dehydrogenase (G-6-PD) deficiency
- 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 :
April 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT02273518
Start Date
April 1 2001
Last Update
October 24 2014
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