This is an open-label, crossover, randomized, single dose, three treatments, three periods and six sequences, single dosage, balanced study to determine Bioequivalence of Isotretinoin. Bioequivalence will be compared between the reference medication one (T1) vs the test medication (T3): (T1 vs T3); and the reference medication two (T2), vs test medication (T3): (T2 vs T3). Finally, treatments T1 vs T2 will be compared statistically to determine if they are bioequivalent.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Isotretinoin reference medication 1 will be 40 mg in the pharmaceutical form of capsule (2 capsules of 20 mg each)
Isotretinoin reference medication 2 will be 40 mg in the pharmaceutical form of capsule (2 capsules of 20 mg each)
Isotretinoin test medication will contain isotretinoin 40 mg (2 capsules of 20 mg each) in the same type of pharmaceutical presentation, containing the same drug but possible to have a different excipients.
GSK Investigational Site
Monterrey, Nuevo León, Mexico
Area under the plasma concentration-time curve from zero hours to last quantifiable time (AUC0-t)
Bioequivalence will be evaluated for isotretinoin 40 mg using three distinct medications; two assigned as reference medication (T1 and T2) and 1 test medication (T3). Each subject will receive 2 capsules (20 mg each) orally.
Time frame: Pre-dose and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36.0, 48.0, 60.0, 72.0 and 96.0 hours post dose in each treatment period
Area under the plasma concentration-time curve from zero hours to infinite (AUC0-infinity)
Bioequivalence will be evaluated for isotretinoin 40 mg using three distinct medications; two assigned as reference medication (T1 and T2) and 1 test medication (T3). Each subject will receive 2 capsules (20 mg each) orally.
Time frame: Pre-dose and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36.0, 48.0, 60.0, 72.0 and 96.0 hours post dose in each treatment period
Maximum drug concentration (Cmax)
Bioequivalence will be evaluated for isotretinoin 40 mg using three distinct medications; two assigned as reference medication (T1 and T2) and 1 test medication (T3). Each subject will receive 2 capsules (20 mg each) orally.
Time frame: Pre-dose and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36.0, 48.0, 60.0, 72.0 and 96.0 hours post dose in each treatment period
Time to maximum drug concentration (Tmax)
Bioequivalence will be evaluated for isotretinoin 40 mg using three distinct medications; two assigned as reference medication (T1 and T2) and 1 test medication (T3). Each subject will receive 2 capsules (20 mg each) orally.
Time frame: Pre-dose and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36.0, 48.0, 60.0, 72.0 and 96.0 hours post dose in each treatment period
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