Comparative assessment in healthy male volunteers under fasting conditions of the absorption and pharmacokinetics of 3 generic formulations of isotretinoin capsules against the innovator isotretinoin capsule in a pilot study
- Conditions
- Pilot study conducted in healthy volunteers comparing four formulations of isotretinoin 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, isotretinoin is a medicine that is used to treat severe forms of acne.Pilot study conducted in healthy volunteers comparing four formulations of isotretinoin 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, isotretinoin is a medicine that is used to treat severe forms of acne.Other - Research that is not of generic health relevance and not applicable to specific health categories listed above
- Registration Number
- ACTRN12615001083583
- Lead Sponsor
- Zenith Technology Corp Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 15
Healthy males
Aged between 18 and 55 years
Non-smoker
BMI greater than or equal to 19 and less than 30 inclusive
Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests
Drug free as determined by urine drug testing
Able to comply with the study restrictions
Able to provide written information consent
Females
Concomitant drug therapy of any kind
History of depression or other mental illness, or a history of epilepsy or seizures
History of conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
History of alcohol or drug abuse or dependency
Sensitivities to Vitamin A or food such as liver
Participation in a drug study within 60 days of the start of the study or undertaking to donate blood within 60 days after the completion of the study
Sensitivities to isotretinoin, its excipients or any other retinoids
Individuals 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 evaluate the pharmacokinetics (as summarised by Cmax and AUC) of the three test formulations relative to that of the reference formulation. All plasma samples will be assayed for isotretinoin using one fully validated LC/MS/MS method. Validation will be conducted to comply with FDA guidelines.[0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0, 9.0, 10.0, 12.0, 16.0, 20.0, 24.0, 32.0, 48.0, 56.0 and 72 hours after 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, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0, 9.0, 10.0, 12.0, 16.0, 20.0, 24.0, 32.0, 48.0, 56.0 and 72 hours after dosing.]