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

NCT ID: NCT02273518

Last Updated: 2014-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-04-30

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Asasantin ER, new formulation I

Group Type: EXPERIMENTAL

Asasantin ER, new formulation I

Intervention Type: DRUG

Asasantin ER, new formulation II

Group Type: EXPERIMENTAL

Asasantin ER, new formulation II

Intervention Type: DRUG

Asasantin ER, present commercial formulation

Group Type: ACTIVE_COMPARATOR

Asasantin ER, present commercial formulation

Intervention Type: DRUG

Interventions

Asasantin ER, new formulation I

Intervention Type: DRUG

Asasantin ER, new formulation II

Intervention Type: DRUG

Asasantin ER, present commercial formulation

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

9.144

Identifier Type: -

Identifier Source: org_study_id