Clinical trial NCT02273492: Impact of Food on Pharmacokinetics and Pharmacodynamics of Asasantin ER in Healthy Subjects
Official title: Impact of Food on Pharmacokinetics and Pharmacodynamics of Asasantin Extended Release (ER) 200/25 mg Capsules b.i.d. in a Randomized, Open, 2-way Cross-over 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: 28
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 and pharmacodynamics of Asasantin ER at fasted and fed state


Eligibility criteria: Inclusion Criteria:

* Healthy subjects as determined by results of screening
* Signed written 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 disorders
* Surgery of the gastro-intestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
* Chronic or relevant acute infections
* History of 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 results 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)
* Excessive physical activities (\< 5 days prior to administration)
* History of hemorrhagic diatheses
* History of gastro-intestinal ulcer, perforating or bleeding
* History of bronchial asthma
* Any laboratory value outside the normal range of clinical relevance

Female subjects:

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

Primary outcomes:
measure: Area under the concentration-time curve of dipyridamole in plasma at steady state (AUCss)
timeFrame: Up to 144 hours
measure: Maximum concentration of dipyridamole in plasma at steady state (Cmax,ss)
timeFrame: Up to 144 hours
measure: Change in Inhibition of cyclooxygenase for acetylsalicylic acid (ASA), analyte thromboxane B2 (TXB2)
timeFrame: up to day 19
measure: Maximum concentration of dipyridamole in plasma from 0 to 10h (Cmax,0-10h)
timeFrame: up to 10 hours after drug administration
Secondary outcomes:
measure: Ratio of peak concentration of the analytes in plasma over area under the curve at steady state (Cmax,ss / AUC,ss)
timeFrame: Up to 144 hours
measure: Area under the concentration-time curve of the analyte in plasma from 0 to 10 h (AUC0-10h)
timeFrame: Up to 10 hours after start of drug administration
measure: Percent peak trough fluctuation of dipyridamole in plasma (%PTF)
timeFrame: Up to 144 hours
measure: Time to reach the maximum concentration of the analytes in plasma at steady state (Tmax,ss)
timeFrame: Up to 144 hours
measure: Terminal half-life of the analytes in plasma (t1/2)
timeFrame: Up to 144 hours
measure: Percent area under the curve fluctuation of dipyridamole in plasma (AUCfluct)
timeFrame: Up to 144 hours
measure: Area under the concentration-time curve of ASA in plasma at steady state (AUCss)
timeFrame: Up to 144 hours
measure: Maximum concentration of ASA in plasma at steady state (Cmax,ss)
timeFrame: Up to 144 hours
measure: Change in Inhibition of cyclooxygenase for acetylsalicylic acid (ASA), analyte malondialdehyde
timeFrame: up to day 19
measure: Number of subjects with clinically significant changes in vital signs (blood pressure, pulse rate)
timeFrame: up to day 7
measure: Number of subjects with abnormal changes in laboratory parameters
timeFrame: Up to 144 hours
measure: Number of subjects with adverse events
timeFrame: up to 2 months
Other outcomes:
Locations:
Study officials:
References: