Study to Compare the Pharmacokinetics of Dipyridamole in Three Different Asasantin Extended Release (ER) Formulations in Healthy Male and Female Volunteers

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Comparative pharmacokinetics of dipyridamole in two new formulations of Asasantin ER compared to the present commercial formulation

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Aspirin, Dipyridamole Drug Combination; Dipyridamole

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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