- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02273518
Study to Compare the Pharmacokinetics of Dipyridamole in Three Different Asasantin Extended Release (ER) Formulations in Healthy Male and Female Volunteers
October 23, 2014 updated by: Boehringer Ingelheim
A Double-blind, Randomised, 3-way Cross-over Study to Compare the Pharmacokinetics of Dipyridamole in Three Different Asasantin ER Extended Release (ER) 200 mg Dipyridamole/25 mg ASA Formulations in Healthy Male and Female Volunteers
Comparative pharmacokinetics of dipyridamole in two new formulations of Asasantin ER compared to the present commercial formulation
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
18
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
21 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All participants in the study should be healthy males or females, range from 21 to 50 years of age and be within ± 20 % of their normal weight (Broca-Index)
- Prior to admission to the study all volunteers will have given, in accordance with good clinical practice (GCP) and the local legislation, their written informed consent
- Subsequently each subject will have his medical history taken and will receive a complete medical examination (incl. blood pressure and pulse rate measurements) as well as a 12-lead ECG
- Hematopoietic, hepatic and renal function tests will be carried out in the laboratory
- The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations
- The above mentioned examinations will be performed within 14 days before the first administration of the test substance
Exclusion Criteria:
- Volunteers are excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
- Subjects with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Subjects with diseases of the central nervous system (such as epilepsy) or with psychiatric or neurological disorders
- History of orthostatic hypotension, fainting spells or blackouts
- Subjects with chronic or relevant acute infections
- Subjects with allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Volunteers who have taken a drug with a long half-life (≥ 24 hours) within one month or less than ten half-lives of the respective drug before enrolment in the study
- Volunteers who receive any other drugs which might influence the results of the trial during the week previous to enrolment in the study
- Volunteers who participate in another study with an investigational drug within the last two months preceding the study
- Volunteers who are unable to refrain from smoking on study days
- Volunteers who smoke more than10 cigarettes (or equivalent) per day
- Volunteers who drink more than 60 g of alcohol per day
- Volunteers who are dependent on drugs
- Volunteers who donate blood (≥ 100 mL) within the last four weeks
- Volunteers who participate in excessive physical activities within the last week before the study (e.g. competitive sports)
- Volunteers who suffer from any other disease or abnormality of clinical relevance
- History of hemorrhagic diatheses
- History of gastro-intestinal ulcer, perforation or bleeding
- History of bronchial asthma
- History of glucose-6-phosphate dehydrogenase (G-6-PD) deficiency
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
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Asasantin ER, present commercial formulation
|
|
Experimental: Asasantin ER, new formulation I
|
|
Experimental: Asasantin ER, new formulation II
|
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 (AUC,ss)
Time Frame: Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
Percent peak trough fluctuation of dipyridamole in plasma (%PTF)
Time Frame: Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum concentration of the analytes in plasma at steady state (Cmax,ss)
Time Frame: Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
Minimum measured concentration of the analytes in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Time Frame: Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
Time from dosing to the maximum measured concentration of the analytes in plasma at steady state over a uniform dosing interval τ Time from dosing to the maximum measured concentration of the analytes in plasma at steady state (tmax,ss)
Time Frame: Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
Percent area under the curve fluctuation of the analytes in plasma (AUCfluct)
Time Frame: Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
Terminal half-life of the analytes in plasma (t1/2)
Time Frame: Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
Percent of dose of the analytes recovered unchanged in urine (Ae%)
Time Frame: Up to 24 hours after start of drug administration
|
Up to 24 hours after start of drug administration
|
Ratio of peak concentration of the analytes in plasma over area under the curve at steady state (Cmax,ss / AUC,ss)
Time Frame: Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
Number of subjects with clinically relevant changes in vital signs (blood pressure, pulse rate)
Time Frame: up to 8 days after last study drug administration
|
up to 8 days after last study drug administration
|
Number of subjects with clinically relevant changes in 12-lead ECG
Time Frame: up to 8 days after last study drug administration
|
up to 8 days after last study drug administration
|
Number of subjects with clinically relevant changes in laboratory values
Time Frame: up to 8 days after last study drug administration
|
up to 8 days after last study drug administration
|
Number of subjects with adverse events
Time Frame: up to 8 days after last study drug administration
|
up to 8 days after last study drug administration
|
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
April 1, 2001
Primary Completion (Actual)
May 1, 2001
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
- 9.144
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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