Comparative assessment of the absorption of a test formulation of 1 x 40 mg isotretinoin capsule against the innovator 1 x 40 mg isotretinoin capsule conducted under fasting conditions in healthy male volunteers.

INTERVENTION: Single dose, crossover study design whereby each participant receives the test formulation of isotretinoin, 1 x 40 mg capsule on one occasion and the innovator formulation of isotretinoin, 1 x 40 mg capsule on one occasion with each dose separated by a two week washout period. The intervention for this trial is the test formulation of isotretinoin. No water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for the water consumed with each dose). Participants are required not to eat for 10 hours before dosing and to fast for approximately 4 hours after each dose. Bathroom visits will be supervised to ensure no unauthorized water or food intake and for personal safety. Participants will be confined at the Clinical Site for 12 hours prior to dosing to ensure compliance and for 24 hours after dosing. Participants will be monitored for adverse events throughout the study. Standard meals will be consumed at the Clinical Site with no additional food intake allowed. Alcohol breath testing will be performed upon each participant reporting to the Clinical Site 12 hours prior to dosing. Pre and post study laboratory tests will be completed to assess the health of the participants along with HIV, Hepatitis and drugs of abuse testing. Each dose will be taken orally with 240 ml of water at ambient temperature. Medication must be swallowed whole and a mouth check will be conducted to ensure that the medication has been taken as directed. CONDITION: Isotretinoin is a medicine that is used to treat severe forms of acne.; ; Isotretinoin is a medicine that is used to treat severe forms of acne. Skin ‐ Dermatological conditions PRIMARY OUTCOME: To evaluate the pharmacokinetics (as summarised by Cmax and AUC) of the test formulation 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.[‐10, ‐2, 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 16, 20, 24, 36, 48, 60 and 72 hours post dosing.] SECONDARY OUTCOME: 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.[‐10, ‐2, 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 16, 20, 24, 36, 48, 60 and 72 hours post dosing.] INCLUSION CRITERIA: Healthy males Aged between 18 and 55 years Non‐smoker BMI greater than or equal to 18.5 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 informed consent