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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Asasantin ER, new formulation II; Drug: Asasantin ER, new formulation I; Drug: Asasantin ER, present commercial formulation

• Registration Number: NCT02273518
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2001-04
• Primary Completion: 2001-05
• Status Verified: 2014-10
• Study First Submitted: 2014-10-23
• Study First Submitted QC: 2014-10-23
• Last Update Submitted: 2014-10-23
• Study First Posted: 2014-10-24
• Last Update Posted: 2014-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Asasantin ER, new formulation II	Asasantin ER, new formulation II	-
Asasantin ER, new formulation I	Asasantin ER, new formulation I	-
Asasantin ER, present commercial formulation	Asasantin ER, present commercial formulation	-

Primary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of dipyridamole in plasma at steady state (AUC,ss)	Up to 48 hours after start of drug administration
Percent peak trough fluctuation of dipyridamole in plasma (%PTF)	Up to 48 hours after start of drug administration

Secondary Outcome Measures

Name	Time	Method
Number of subjects with adverse events	up to 8 days after last study drug administration
Minimum measured concentration of the analytes in plasma at steady state over a uniform dosing interval τ (Cmin,ss)	Up to 48 hours after start of drug administration
Time from dosing to the maximum measured concentration of the analytes in plasma at steady state over a uniform dosing interval τ Time from dosing to the maximum measured concentration of the analytes in plasma at steady state (tmax,ss)	Up to 48 hours after start of drug administration
Percent area under the curve fluctuation of the analytes in plasma (AUCfluct)	Up to 48 hours after start of drug administration
Maximum concentration of the analytes in plasma at steady state (Cmax,ss)	Up to 48 hours after start of drug administration
Terminal half-life of the analytes in plasma (t1/2)	Up to 48 hours after start of drug administration
Percent of dose of the analytes recovered unchanged in urine (Ae%)	Up to 24 hours after start of drug administration
Ratio of peak concentration of the analytes in plasma over area under the curve at steady state (Cmax,ss / AUC,ss)	Up to 48 hours after start of drug administration
Number of subjects with clinically relevant changes in 12-lead ECG	up to 8 days after last study drug administration
Number of subjects with clinically relevant changes in vital signs (blood pressure, pulse rate)	up to 8 days after last study drug administration
Number of subjects with clinically relevant changes in laboratory values	up to 8 days after last study drug administration