Study to Evaluate Pharmacokinetics of Dipyridamole in Three New Formulations of Asasantin ER in Healthy Female and Male Subjects
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ClinicalTrials.gov Identifier: NCT02273544 |
Recruitment Status :
Terminated
First Posted : October 24, 2014
Last Update Posted : October 24, 2014
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Sponsor:
Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim
Tracking Information | |||
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First Submitted Date ICMJE | October 23, 2014 | ||
First Posted Date ICMJE | October 24, 2014 | ||
Last Update Posted Date | October 24, 2014 | ||
Study Start Date ICMJE | September 2002 | ||
Actual Primary Completion Date | October 2002 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Urinary excretion of dipyridamole [ Time Frame: day 2, day 3 ] geometric means of percentage of amount excreted from time zero to 10 h (% Ae 0-10h)
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Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | No Changes Posted | ||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Study to Evaluate Pharmacokinetics of Dipyridamole in Three New Formulations of Asasantin ER in Healthy Female and Male Subjects | ||
Official Title ICMJE | Bioavailability of Dipyridamole After Asasantin (Extended Release 200mg Dipyridamole/25mg ASA) in 3 Experimental Formulations (Given b.i.d. Over 3 or 5 Days, Respectively) Relative to the Standard Formulation in 16 Healthy Female and Male Subjects. Intraindividual Comparison, Randomised, Open | ||
Brief Summary | 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 b.i.d. treatment | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 1 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Healthy | ||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Terminated | ||
Actual Enrollment ICMJE |
16 | ||
Original Actual Enrollment ICMJE | Same as current | ||
Study Completion Date ICMJE | Not Provided | ||
Actual Primary Completion Date | October 2002 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
For Female Subjects:
During the interval between screening and start of drug administration tobacco and caffeine are restricted to avoid withdrawal when starting medication. As no relevant influence on Pharmacokinetic parameters is known moderate tobacco and caffeine consumption are allowed to facilitate trial participation (up to 10 cigarettes or 3 cigars or 3 pipes/day, and/or up to three cups of coffee respectively). Ovarian hormone substitution and oral contraception are allowed to be continued during the study |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 60 Years (Adult) | ||
Accepts Healthy Volunteers ICMJE | Yes | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Not Provided | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT02273544 | ||
Other Study ID Numbers ICMJE | 9.158 | ||
Has Data Monitoring Committee | Not Provided | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Boehringer Ingelheim | ||
Study Sponsor ICMJE | Boehringer Ingelheim | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Boehringer Ingelheim | ||
Verification Date | October 2014 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |