Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Compare the Pharmacokinetics of Dipyridamole in Three Different Asasantin Extended Release (ER) Formulations in Healthy Male and Female Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02273518
Recruitment Status : Completed
First Posted : October 24, 2014
Last Update Posted : October 24, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Comparative pharmacokinetics of dipyridamole in two new formulations of Asasantin ER compared to the present commercial formulation

Condition or disease Intervention/treatment Phase
Healthy Drug: Asasantin ER, new formulation I Drug: Asasantin ER, new formulation II Drug: Asasantin ER, present commercial formulation Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2001
Actual Primary Completion Date : May 2001

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Asasantin ER, new formulation I Drug: Asasantin ER, new formulation I
Experimental: Asasantin ER, new formulation II Drug: Asasantin ER, new formulation II
Active Comparator: Asasantin ER, present commercial formulation Drug: Asasantin ER, present commercial formulation



Primary Outcome Measures :
  1. 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 ]
  2. Percent peak trough fluctuation of dipyridamole in plasma (%PTF) [ Time Frame: Up to 48 hours after start of drug administration ]

Secondary Outcome Measures :
  1. Maximum concentration of the analytes in plasma at steady state (Cmax,ss) [ Time Frame: Up to 48 hours after start of drug administration ]
  2. 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 ]
  3. 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 ]
  4. Percent area under the curve fluctuation of the analytes in plasma (AUCfluct) [ Time Frame: Up to 48 hours after start of drug administration ]
  5. Terminal half-life of the analytes in plasma (t1/2) [ Time Frame: Up to 48 hours after start of drug administration ]
  6. Percent of dose of the analytes recovered unchanged in urine (Ae%) [ Time Frame: Up to 24 hours after start of drug administration ]
  7. 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 ]
  8. 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 ]
  9. Number of subjects with clinically relevant changes in 12-lead ECG [ Time Frame: up to 8 days after last study drug administration ]
  10. Number of subjects with clinically relevant changes in laboratory values [ Time Frame: up to 8 days after last study drug administration ]
  11. Number of subjects with adverse events [ Time Frame: up to 8 days after last study drug administration ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Additional Information:
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02273518    
Other Study ID Numbers: 9.144
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: October 24, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Aspirin, Dipyridamole Drug Combination
Platelet Aggregation Inhibitors