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

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Asasantin ER, present commercial formulation

Drug: Asasantin ER, new formulation I

Drug: Asasantin ER, new formulation II

Study type

Interventional

Funder types

Industry

Identifiers

NCT02273518

9.144

Details and patient eligibility

About

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

Enrollment

18 patients

Sex

All

Ages

21 to 50 years old

Volunteers

Accepts Healthy Volunteers

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