Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02498288 | A Study to Determine Bioequivalence of Isotretinoin in Healthy Male Subjects Under Fed Condition | PHASE1 | COMPLETED | 36 | — | — | May 31, 2013 | Jul 15, 2013 | Jun 12, 2017 | 1 | Mexico |
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 ...