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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01938508 | Minocycline Bioequivalence Study | PHASE1 | COMPLETED | 28 | — | — | May 1, 2013 | Jun 1, 2013 | Nov 18, 2013 | 1 | Mexico |
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).
| 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 |
| Name | Type | Description |
|---|---|---|
| Minocycline | DRUG | minocycline hydrochloride capsules in microgranules equivalent to 100 mg of minocycline |
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...