Clinical trial NCT02273505: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Area under the plasma concentration-time curve at steady state (AUCss)
timeFrame: Up to 144 hours after drug administration
measure: Percentage peak trough fluctuation (%PTF)
timeFrame: Up to 144 hours after drug administration
Secondary outcomes:
measure: Maximum plasma concentration at steady state (Cmax,ss) of dipyridamole (dp)
timeFrame: Up to 144 hours after drug administration
measure: Maximum plasma concentration at steady state / Area under the plasma concentration-time curve at steady state ((Cmax,ss) / (AUCss)) of dipyridamole
timeFrame: Up to 144 hours after drug administration
measure: Time to reach maximum plasma concentration at steady state (tmax,ss) of dipyridamole
timeFrame: Up to 144 hours after drug administration
measure: Fluctuation of AUC (AUCfluct) of dipyridamole
timeFrame: Up to 144 hours after drug administration
measure: Terminal half-life in the analyte (t1/2) of dipyridamole
timeFrame: Up to 144 hours after drug administration
measure: Urinary excretion (Ae%) of dp, dipyridamole glucuronide (dp-gluc) and salicylic acid (SA)
timeFrame: Up to 106 hours after drug administration
measure: Number of participants with abnormal changes in clinical laboratory parameters
timeFrame: Up to day 7 after last drug administration
measure: Number of participants with Adverse Events
timeFrame: Up to day 7 after last drug administration
Other outcomes:
Locations:
Study officials:
References: