Impact of Food on Pharmacokinetics and Pharmacodynamics of Asasantin ER in Healthy Subjects

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

Comparative pharmacokinetics and pharmacodynamics of Asasantin ER at fasted and fed state

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Standardized breakfast; Drug: Asasantin ER

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

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 after a standardized breakfast	Other: Standardized breakfast; Drug: Asasantin ER
Active Comparator: Asasantin ER at fasted state	Drug: Asasantin ER

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the concentration-time curve of dipyridamole in plasma at steady state (AUCss)	Up to 144 hours
Maximum concentration of dipyridamole in plasma at steady state (Cmax,ss)	Up to 144 hours
Change in Inhibition of cyclooxygenase for acetylsalicylic acid (ASA), analyte thromboxane B2 (TXB2)	up to day 19
Maximum concentration of dipyridamole in plasma from 0 to 10h (Cmax,0-10h)	up to 10 hours after drug administration

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: August 1, 1999
• Primary Completion (Actual): October 1, 1999

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: Platelet Aggregation Inhibitors; Aspirin, Dipyridamole Drug Combination
• Other Study ID Numbers: 9.136