Skin Infections (Acne) Clinical Trial
Official title:
Bioequivalence Study Between Two Medications for Oral Administration of Minocycline in 100 mg Oral Solids in Healthy Volunteers
The aim of the study is to compare the bioavailability of two medications containing 100 mg of minocycline in capsules to determine bioequivalence. They are Minocycline (Minocin® is a registered trademark of Wyeth Holdings Corporation), and Minocycline (Minopac® is a registered trademark of LABORATORIOS DERMATOLOGICOS DARIER, S.A. DE C.V.). Study design is randomized, open, cross-over with two single administrations with two periods and two sequences with a wash-out period of 7 days between the periods. Subjects in the study will be 25 healthy male volunteers, 18-55 years, Blood samples will be obtained at 0.0, 0.33, 0.66, 1.0, 1.33, 1.66, 2.0, 2.33, 2.66, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 48.0, and 72.0 hours after medication administration in each period. Plasma minocycline levels will be determined by HPLC method with UV detection with previously validated method. Minocycline concentration data will be used to calculate Cmax, AUC0-t, and AUC0-inf with WinNonlin 5.3 software. The log transformed pharmacokinetics parameters of test and reference medications will be compared calculating ratios and 90% confidence intervals. Any adverse event will be reported.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01863615 -
Bioequivalence Study for an Isotretinoin
|
Phase 1 |