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.