Comparative assessment of the absorption of a generic formulation of tretinoin capsule against the innovator tretinoin capsule conducted under fasting conditions in healthy male volunteers
- Conditions
- Bioequivalence study conducted in healthy volunteers comparing two formulations of tretinoin with no health condition or problem studied. Although this study is being conducted in healthy volunteers who are not being treated for the condition to which the medicine is used, tretinoin belongs to a class of medicines called retinoid. It is used to induce maturation of acute promyelocytic leukemia (APL) cells in culture. It is indicated for the induction of remission in patients with APL.Bioequivalence study conducted in healthy volunteers comparing two formulations of tretinoin with no health condition or problem studied.Although this study is being conducted in healthy volunteers who are not being treated for the condition to which the medicine is used, tretinoin belongs to a class of medicines called retinoid. It is used to induce maturation of acute promyelocytic leukemia (APL) cells in culture. It is indicated for the induction of remission in patients with APL.Other - Research that is not of generic health relevance and not applicable to specific health categories listed above
- Registration Number
- ACTRN12614000645651
- Lead Sponsor
- Zenith Technology Corp Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 48
Healthy males
Aged between 18 and 55
Non-smoker
BMI between 18 and 33 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
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
Sensitivity to tretinoin any other similar class medicines, excipients of tretinoin
History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
Who are sensitive to Vitamin A or food such as liver, which contain large quantities of Vitamin A.
Who might have an increased sensitivity to sunlight.
Who wear contact lenses.
Who are planning to start a family within 60 days of receiving the final dose.
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 tretinoin (as summarised by Cmax and AUC) for the formulation. All plasma samples will be assayed for tretinoin using one fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines. [-1, -0.5, 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2.0, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10 and 11 hours ]
- 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. [-1, -0.5, 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2.0, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10 and 11 hours];T1/2, the elimination half life will be determined by plasma sample analysis. T1/2 = 0.693/Kel where kel is the terminal elimination rate constant. [-1, -0.5, 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2.0, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10 and 11 hours]