- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02273557
Bioavailability of Dipyridamole of Asasantin p.o. in Three Experimental Formulations Relative to the Standard Formulation in Healthy Male Subjects
October 23, 2014 updated by: Boehringer Ingelheim
Bioavailability of Dipyridamole of Asasantin p.o. (Extended Release 200 mg Dipyridamole/25 mg ASA) in Three Experimental Formulations (Given BID Over 3 Days Each) Relative to the Standard Formulation After a run-in Phase (Persantine ER BID for 2 Days Each: 25 mg, 50 mg, 100 mg; 150 mg [Persantine®]; 200 mg Persantine/25 mg ASA [Asasantin ER] in Healthy Male Subjects. Four-way, Change-over, Randomised, Open
The objective of this study was to compare the pharmacokinetics of dipyridamole in three different Asasantin ER batches (test) containing different amounts of retarding lacquers to the existing commercial product at steady state with BID treatment
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy male subjects as determined by results of screening
- Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- Age >=50 years
- BMI >=18.5 and <=29.9 kg/m2
- Able to communicate well with the investigator and to comply with study requirements
- Laboratory values within a clinically defined reference range
Exclusion Criteria:
- Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- 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 (< 3 months prior to administration (at least 10 times the relevant elimination half-life) or during trial)
- Having had prescription medication 2 weeks prior to study drug administration or over the counter medication 1 week prior to study drug administration (at least 10 times the relevant elimination half-life)
- Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day)
- Alcohol abuse (> 60 g/day)
- Drug abuse
- Blood donation or loss > 400 mL (< 1 month prior to administration or during the trial)
- Excessive physical activities (< 5 days prior to administration or during the trial)
- Any ECG value outside of the reference range of clinical relevance including, but not limited to QTcB > 480 ms or QRS interval > 110 ms
- History of any familial bleeding disorder
- Inability to comply with dietary regimen of study centre
- Inability to comply with investigator's instructions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Asasantin ER (new formulation I - low)
|
|
Experimental: Asasantin ER (new formulation III - medium)
|
|
Experimental: Asasantin ER (new formulation II - high)
|
|
Active Comparator: Asasantin ER (present commercial formulation)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urinary excretion of dipyridamole
Time Frame: day 2, day 3
|
represented by the sum of percentage of amount excreted from time zer0 to 10 h (%Ae 0-10 h), %Ae 10-24h
|
day 2, day 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax urine (Maximum measured concentration of the analyte)
Time Frame: 0 to 3 hours after drug intake
|
Urine collected fraction from 0 -3 hours as surrogate for Cmax
|
0 to 3 hours after drug intake
|
Cmin urine (Minimum measured concentration of the analyte)
Time Frame: 8- 10 hours after drug intake
|
Urine collected fraction from 8 - 10 hours as surrogate for Cmin
|
8- 10 hours after drug intake
|
%PTF urine (Peak trough fluctuation)
Time Frame: Up to 10 hours after drug intake
|
Estimated from the difference of percentage amount excreted from 1 - 3 hours (%Ae (1-3hours) and %Ae (8-10 hours) divided by the average excretion rate over the total dosing interval
|
Up to 10 hours after drug intake
|
Number of subjects with adverse events
Time Frame: up to 23 days
|
up to 23 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2003
Primary Completion (Actual)
February 1, 2003
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
Other Study ID Numbers
- 9.163
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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