Comparison of Pharmacokinetics of Dipyridamole in Asasantin Extended Release (ER) and in a Combination of Persantin Immediate Release Tablets and ASA Tablets in Healthy Subjects

NCT ID: NCT02273505

Last Updated: 2014-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-04-30

Brief Summary

Comparative Pharmacokinetics of Asasantin Extended Release (ER) and of immediate release Persantin tablets combined with Acetyl salicylic acid (ASA) tablets

Conditions

Healthy

Study Design

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

Study Groups

Asasantin (ER)

Group Type: EXPERIMENTAL

Asasantin (ER)

Intervention Type: DRUG

Combination of Persantin and ASA

Group Type: ACTIVE_COMPARATOR

Persantin

Intervention Type: DRUG

Acetyl salicylic acid (ASA)

Intervention Type: DRUG

Interventions

Asasantin (ER)

Intervention Type: DRUG

Persantin

Intervention Type: DRUG

Acetyl salicylic acid (ASA)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy subjects as determined by results of screening
• Signed informed consent in accordance with Good Clinical Practice (GCP) and local legislation
• Age >= 18 and <= 55 years
• Broca >= - 20% and <= + 20%

Exclusion Criteria

• Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorder
• Surgery of the gastro-intestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• Chronic or relevant acute infections
• History or hypersensitivity to Asasantin ER and any of the excipients
• 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 result of the trial (<= 10 days prior to administration or during the trial)
• Participation in another trial with an investigational drug (<= 1 month prior to administration or during the trial)
• Known alcohol abuse
• Known drug abuse
• Blood donation ( <=1 month prior to administration or during the trial)
• Excessive physical activities (<=5 days prior to administration or during the trial)
• History of hemorrhagic diseases
• History of gastro-intestinal ulcer, perforation or bleeding
• History of bronchial asthma
• Any laboratory value outside the reference range of clinical relevance

For female subjects:

• Pregnancy
• Positive pregnant test
• No adequate contraception (adequate contraception e.g. sterilization, intrauterine device (IUD), oral contraceptives)
• Inability to maintain this adequate contraception during the whole study period
• Lactation period

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

9.138

Identifier Type: -

Identifier Source: org_study_id