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TA Base Rate
Adjusted LOA
ML Risk
Isotretinoin: Reference Medication 1 · 1 trial · 1 indication
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Isotretinoin Arm | EXPERIMENTAL | All subjects in this study will be randomized to receive all the 3 distinct medications of isotretinoin in a sequential manner. Subjects will receive a single dosage of two capsules x 20 mg (40 mg) orally, for three periods, six sequences, with a wash-out period of two weeks to eliminate the first dosage. |
| Name | Type | Description |
|---|---|---|
| Isotretinoin: Reference Medication 1 | DRUG | Isotretinoin reference medication 1 will be 40 mg in the pharmaceutical form of capsule (2 capsules of 20 mg each) |
| Isotretinoin: Reference Medication 2 | DRUG | Isotretinoin reference medication 2 will be 40 mg in the pharmaceutical form of capsule (2 capsules of 20 mg each) |
| Isotretinoin: Test Medication | DRUG | 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. |
Inclusion Criteria: * Included in study will be male volunteers. * Ages between 18 and 45 years old. * BMI (Body Mass Index) between 20 to 26 kilogram/meter square (kg/m\^2). * Anti-doping tests negative results. * Negative test results for Ac human immunodeficiency virus (HIV), HBsAg (hepatitis B ...
Isotretinoin is a small molecule medication being studied for the treatment of acne vulgaris. It is currently in Phase 1 clinical development as an investigational drug. The reference medication is being evaluated in a bioequivalence study involving healthy male subjects under fed conditions.
Isotretinoin is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical research on this small molecule for the dermatology indication of acne vulgaris.
Isotretinoin is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 clinical trial has been completed for this medication, which was a bioequivalence study in healthy male subjects.
Isotretinoin has one completed clinical trial registered under NCT02498288, titled "A Study to Determine Bioequivalence of Isotretinoin in Healthy Male Subjects Under Fed Condition." This Phase 1 study enrolled 36 healthy male participants in Mexico and was not randomized or double-blinded.
Isotretinoin is identified as "Reference Medication 1" in the clinical trial data. This designation indicates it serves as the reference product in a bioequivalence study, meaning it is the standard medication against which a test product is compared.