Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Minocycline · 2 trials · 2 indications
The following pharmacokinetic (PK) parameters will assessed maximum observed concentration (Cmax), Area under the concentration time curve from time zero (pre-dose) to last common time of quantifiable concentration within a subject across all treatments (AUC0-t) and Area under the concentration time curve from time zero (pre-dose) extrapolated to infinite time (AUC0-inf).
Pharmacokinetics
Pharmacokinetics
| Arm | Type | Description |
|---|---|---|
| Test | EXPERIMENTAL | Minocycline 100 mg capsules Darier SA Dermatological Laboratories de CV (Micromycin ®). |
| Reference | EXPERIMENTAL | Minocycline 100 mg capsules (Micocin ®) Marketed and distributed by Triax Pharmaceuticals |
| 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 |
|---|---|---|
| Minocycline | DRUG | minocycline hydrochloride capsules in microgranules equivalent to 100 mg of minocycline |
| Minocycline 100mg | DRUG | Test product |
Inclusion Criteria: * Subjects aged between 18 and 55 years, of both genders. * Subjects who are in good health, based on the results of a complete medical history, valid for 6 months prior to baseline. * Subjects with laboratory studies, liver transaminases, hepatitis B test and C, HIV and Venerea...
Minocycline is a small molecule being developed for dermatology conditions, specifically skin infections such as acne and other skin diseases. It is currently in Phase 1 clinical development as an investigational drug.
Minocycline is being developed by GSK plc, a pharmaceutical company traded on the stock exchange under the ticker GSK.
Minocycline is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities.
Minocycline has been studied in two completed Phase 1 bioequivalence trials. One trial, NCT01755611, enrolled 25 healthy male volunteers aged 18 years and older for skin infections (acne). Another trial, NCT01938508, enrolled 28 participants of all sexes in Mexico for skin diseases.
Minocycline is a distinct drug being developed for acne and skin diseases. It is not known to be the same as any other named acne treatment, as it is being studied as a standalone investigational agent.