Comparative assessment of the absorption of a generic formulation of aspirin/dipyridamole extended release capsule against the innovator aspirin/dipyridamole extended release capsule conducted under fasting conditions in healthy male and female volunteers

Phase 1

Completed

• Registration Number: ACTRN12614000276651
• Lead Sponsor: Zenith Technology Corporation Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Healthy males and non-pregnant females
Aged between 18 and 55
Non-smoker
BMI between 19 and 30
Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests
Able to provide written informed consent

Exclusion Criteria

Any history of recent recurrent attacks of bronchitis, asthma, migraine headaches
Concomitant drug therapy of any kind excluding prescribed hormonal contraceptives
Who have receievd an investigational compound or drug known to induce or inhibit liver enqymes within 60 days of the start of the study
History or family history of depression or other mental illness, epilepsy or seizures
Who have a histroy of bleeding disorders or blood clotting problems
Sensitivity to aspirin/dipyridamole, any other antithrombotic/ platelet aggregation inhibitor medicines, excipients of aspirin/dipyridamole
History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
Who are lactose intolerant
Females who are breastfeeding or are planning to start a family within 60 days of dosing
Who are planning on having any surgical or dental procedures within 4 weeks of the study completion
Smoker (anyone who has smoked in the last 6 months)
History of alcohol or drug abuse or dependency
Participation in a drug study within 60 days of the start of the study or donated blood in the 60 days preceding the study.
Volunteers for whom the Clinical Investigator believes, for any reason, that participation would not be an acceptable risk.

Study & Design

• Study Type: Interventional
• Study Design: Not specified