Comparative assessment of the absorption of a generic formulation of 500 mg tranexamic acid tablet against the innovator 500 mg tranexamic acid tablet conducted under fasting conditions in healthy male and female volunteers
- Registration Number
- ACTRN12615001005549
- Lead Sponsor
- Zenith Technology Corp Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 27
Healthy males and Females
Aged between 18 and 55
Non-smoker
BMI between 18 and 33
Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests
Able to provide written informed consent
Any history of recent recurrent attacks of bronchitis, asthma, migraine headaches
Concomitant drug therapy of any kind
History of or family history of thromboembolic disease such as deep vein thrombosis (DVT), pulmonary embolism and cerebral thrombosis, antithrombin III deficiency or Factor V Leiden mutation.
Any acquired colour vision disturbance.
Pregnant or breast-feeding
Sensitivity to tranexamic acid or any excipients of tranexamic acid
History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method