Bioavailability of Dipyridamole of Asasantin p.o. in Three Experimental Formulations Relative to the Standard Formulation in Healthy Male Subjects

NCT ID: NCT02273557

Last Updated: 2014-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-31

Brief Summary

The objective of this study was to compare the pharmacokinetics of dipyridamole in three different Asasantin ER batches (test) containing different amounts of retarding lacquers to the existing commercial product at steady state with BID treatment

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Asasantin ER (new formulation I - low)

Group Type: EXPERIMENTAL

Asasantin ER (new formulation I - low)

Intervention Type: DRUG

Asasantin ER (new formulation III - medium)

Group Type: EXPERIMENTAL

Asasantin ER (new formulation III - medium)

Intervention Type: DRUG

Asasantin ER (new formulation II - high)

Group Type: EXPERIMENTAL

Asasantin ER (new formulation II - high)

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 - low)

Intervention Type: DRUG

Asasantin ER (new formulation III - medium)

Intervention Type: DRUG

Asasantin ER (new formulation II - high)

Intervention Type: DRUG

Asasantin ER (present commercial formulation)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy male subjects as determined by results of screening
• Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
• Age >=50 years
• BMI >=18.5 and <=29.9 kg/m2
• Able to communicate well with the investigator and to comply with study requirements
• Laboratory values within a clinically defined reference range

Exclusion Criteria

• Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic or hormonal disorders
• Surgery of gastrointestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• Intake of drugs with a long half-life (> 24 hours) (< 1 month prior to administration or during the trial)
• Use of any drugs, which might influence the results of the trial, (< 10 days prior to administration or during the trial)
• Participation in another trial with an investigational drug (< 3 months prior to administration (at least 10 times the relevant elimination half-life) or during trial)
• Having had prescription medication 2 weeks prior to study drug administration or over the counter medication 1 week prior to study drug administration (at least 10 times the relevant elimination half-life)
• Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day)
• Alcohol abuse (> 60 g/day)
• Drug abuse
• Blood donation or loss > 400 mL (< 1 month prior to administration or during the trial)
• Excessive physical activities (< 5 days prior to administration or during the trial)
• Any ECG value outside of the reference range of clinical relevance including, but not limited to QTcB > 480 ms or QRS interval > 110 ms
• History of any familial bleeding disorder
• Inability to comply with dietary regimen of study centre
• Inability to comply with investigator's instructions

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

9.163

Identifier Type: -

Identifier Source: org_study_id