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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Acetyl salicylic acid (ASA); Drug: Persantin; Drug: Asasantin (ER)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02273505

9.138

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Asasantin (ER)

Experimental group

Treatment:

Drug: Asasantin (ER)

Combination of Persantin and ASA

Active Comparator group

Treatment:

Drug: Persantin

Drug: Acetyl salicylic acid (ASA)