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

Comparison of Pharmacokinetics of Dipyridamole in Asasantin Extended Release (ER) 200/25 mg Capsules Bid and in a Combination of Persantin Immediate Release Tablets (100 mg Qid) and ASA Tablets (25 mg Bid) in an Open, Randomized, 2-way Crossover Study in Healthy Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Asasantin (ER); Drug: Persantin; Drug: Acetyl salicylic acid (ASA)

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Asasantin (ER)	Drug: Asasantin (ER)
Active Comparator: Combination of Persantin and ASA	Drug: Persantin; Drug: Acetyl salicylic acid (ASA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the plasma concentration-time curve at steady state (AUCss)	Up to 144 hours after drug administration
Percentage peak trough fluctuation (%PTF)	Up to 144 hours after drug administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum plasma concentration at steady state (Cmax,ss) of dipyridamole (dp)	Up to 144 hours after drug administration
Maximum plasma concentration at steady state / Area under the plasma concentration-time curve at steady state ((Cmax,ss) / (AUCss)) of dipyridamole	Up to 144 hours after drug administration
Time to reach maximum plasma concentration at steady state (tmax,ss) of dipyridamole	Up to 144 hours after drug administration
Fluctuation of AUC (AUCfluct) of dipyridamole	Up to 144 hours after drug administration
Terminal half-life in the analyte (t1/2) of dipyridamole	Up to 144 hours after drug administration
Urinary excretion (Ae%) of dp, dipyridamole glucuronide (dp-gluc) and salicylic acid (SA)	Up to 106 hours after drug administration
Number of participants with abnormal changes in clinical laboratory parameters	Up to day 7 after last drug administration
Number of participants with Adverse Events	Up to day 7 after last drug administration

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: April 1, 2000
• Primary Completion (Actual): May 1, 2000

Study Registration Dates

• First Submitted: October 23, 2014
• First Submitted That Met QC Criteria: October 23, 2014
• First Posted (Estimate): October 24, 2014

Study Record Updates

• Last Update Posted (Estimate): October 24, 2014
• Last Update Submitted That Met QC Criteria: October 23, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Anti-Infective Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Dermatologic Agents; Antifungal Agents; Keratolytic Agents; Phosphodiesterase Inhibitors; Aspirin; Dipyridamole; Salicylic Acid; Salicylates; Aspirin, Dipyridamole Drug Combination
• Other Study ID Numbers: 9.138