Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Isotretinoin · 1 trial · 1 indication
pharmacokinetics
pharmacokinetics
| Arm | Type | Description |
|---|---|---|
| A(reference)/B(test) | EXPERIMENTAL | initial administration of reference and cross-over to test |
| B(test)/A(reference) | EXPERIMENTAL | initial administration of test and cross-over to reference |
| Name | Type | Description |
|---|---|---|
| Isotretinoin 40 mg | DRUG | Roaccutan 2 capsules of 20 mg; reference drug |
Inclusion Criteria: Male volunteers. Ages between 18 and 45 years old. BMI (Body Mass Index) between 20 to 26 kg/m2. Anti-doping tests negative results. Clinical biochemical test values: Hematic Biometry, Urine Analysis, Biochemical Profile: (Glucose, Ureic Nitrogen, Urea, Creatinine, Uric Acid, Ch...
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Isotretinoin is used for skin infections, specifically acne. It is a small molecule being developed by GSK plc for dermatology indications. The drug is currently in Phase 1 clinical development and is being studied for its effects on acne in a clinical trial setting.
Isotretinoin is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug for the treatment of acne, a skin infection.
Isotretinoin is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied for its safety and pharmacokinetics in a clinical trial involving healthy volunteers.
Isotretinoin has one completed clinical trial registered under NCT01863615. This Phase 1 study was a bioequivalence study conducted in Mexico with 36 healthy male participants aged 18 years and older. The trial was controlled but not double-blinded, and it evaluated the drug for acne.
Isotretinoin is not FDA approved based on the available information. It is currently in Phase 1 clinical development, meaning it is still being tested in clinical trials. The drug has not yet completed the clinical development process required for regulatory approval.