Comparative assessment of the absorption of a generic formulation of tadalafil tablet against the innovator tadalafil tablet conducted under fed conditions in healthy male volunteers
- Registration Number
- ACTRN12616000893404
- Lead Sponsor
- Zenith Technology Corp Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Male
- Target Recruitment
- 24
Healthy males
Aged between 18 and 55
Non-smoker
BMI between 19 and 30 inclusive
Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests
Able to provide written informed consent
Females
Any history of recent recurrent attacks of bronchitis, asthma, migraine headaches
Concomitant drug therapy of any kind
Sensitivity to tadalafil or any other similar class of medicines, or the excipients of tadalafil
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 To compare the bioavailability of tadalafil (as summarised by Cmax and AUC) for the formulation. All plasma samples will be assayed for tadalafil using one fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines.[0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 32, 48, 56 and 72 hours post dosing]
- Secondary Outcome Measures
Name Time Method Time to maximum peak concentration (Tmax) will be determined by plasma sample analysis. Tmax will be the time where the maximum concentration occurred in the sample points.[0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 32, 48, 56 and 72 hours post dosing]