- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02273531
Bioequivalence of a New Asasantin Formulation Extended Release (ER) Compared to the Commercially Available Asasantin Formulation (Aggrenox®; Extended Release) in Healthy Male and Female Volunteers
October 23, 2014 updated by: Boehringer Ingelheim
Bioequivalence of a New Asasantin Capsule Formulation (Extended Release Combination 200 mg Dipyridamole/25 mg ASA) Compared to the Commercially Available Asasantin Capsule Formulation (Aggrenox®; Extended Release Combination 200 mg Dipyridamole/25 mg ASA) Following Multiple Oral Administration at Steady State After a run-in Phase (Persantine ER BID for 2 Days Each: 25 mg, 50 mg, 100 mg, 150 mg [Persantine®]; 200 mg Dipyridamole/25 mg ASA [Asasantin ER])- an Open Label, Randomized, Multiple-dose, Two-way Crossover, Change-over Study in Healthy Male and Female Volunteers
Study to establish the bioequivalence of a new formulation of Asasantin ER compared to the present commercially available Asasantin ER formulation (Aggrenox®)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
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 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ECG, clinical laboratory tests:
- No finding deviating from normal and of clinical relevance
- No evidence of a clinically relevant concomitant disease
- Age ≥ 21 and ≤ 65 years
- Body mass index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2
- Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and the local legislation
- Able to communicate well with the investigator and to comply with study requirements
Exclusion Criteria:
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological 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 relevant 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) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
- Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 14 days prior to administration or during the trial
- Participation in another trial with an investigational drug within two months prior to administration or during the trial
- Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)
- Inability to refrain from smoking on trial days Alcohol abuse (more than 60 g/day)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within one week prior to administration or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of study centre
- History of frequent headaches
- History of gastro-intestinal ulcer disease
For female subjects:
- Pregnancy
- Positive pregnancy test
- No adequate contraception e.g. oral contraceptives, sterilization, intrauterine device (IUD)
- 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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Asasantin ER, new formulation
|
|
Active Comparator: Asasantin ER, present commercial formulation
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the concentration-time curve of dipyridamole in plasma over one dosing interval at steady state (AUCτ,ss)
Time Frame: up to 17 days
|
up to 17 days
|
Maximum measured concentration of dipyridamole in plasma at steady state (Cmax,ss)
Time Frame: up to 17 days
|
up to 17 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Minimum measured concentration of dipyridamole in plasma at steady state (Cmin,ss)
Time Frame: up to 17 days
|
up to 17 days
|
Average concentration of dipyridamole in plasma at steady state (Cavg)
Time Frame: up to 17 days
|
up to 17 days
|
Time from dosing to the maximum concentration of dipyridamole in plasma at steady state (tmax,ss)
Time Frame: up to 17 days
|
up to 17 days
|
Peak trough fluctuation of dipyridamole in plasma (PTF)
Time Frame: up to 17 days
|
up to 17 days
|
Amount of the analytes that were eliminated in urine (Ae)
Time Frame: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
Fraction in percent of dose of the analytes that was eliminated in urine (fe)
Time Frame: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
Number of subjects with clinically significant changes in 12-lead ECG
Time Frame: up to 17 days
|
up to 17 days
|
Number of subjects with clinically significant changes in vital signs (blood pressure, pulse rate)
Time Frame: up to 17 days
|
up to 17 days
|
Number of subjects with clinically significant changes in laboratory tests
Time Frame: up to 17 days
|
up to 17 days
|
Number of subjects with adverse events
Time Frame: up to 17 days
|
up to 17 days
|
Assessment of tolerability by the investigator on a 4-point scale
Time Frame: after 17 days
|
after 17 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, 2004
Primary Completion (Actual)
March 1, 2004
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
- 9.149
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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