The study was conducted as an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Minocycline hydrochloride extended release tablets 135 mg manufactured by OHM Laboratories Inc. with SolodynTM extended release tablets 135 mg manufactured by AAI Pharma, Inc Wilmington, NC 28405 and manufactured for Medicis, The Dermatology Company Scottsdale, AZ 85258 in healthy, adult, male, human subjects under fasting condition.
Test for drugs of abuse (opiates and cannabinoids) in urine and breath test for alcohol were carried out prior to admission in each period of the study. Following an overnight fast of at least 10 hour, a single oral dose of minocycline hydrochloride extended release tablet 135 mg of either test or reference formulation was administered during each period of the study, along with 240 mL of drinking water at ambient temperature under low light condition and under supervision of trained study personnel. During the course of the study, safety parameters assessed were vital signs, clinical examination, medical history and clinical laboratory safety tests (hematology, biochemical parameters, serology and urine analysis) at baseline. Adverse event monitoring was done throughout the study. Laboratory parameters of hematology and biochemistry (except blood glucose and cholesterol) were repeated at the end of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
28
extended release tablets 135 mg
Area under the plasma concentration versus time curve (AUC) of Minocycline
Time frame: 0-96 hrs
Peak Plasma Concentration (Cmax) of Minocycline
Time frame: 0-96 hrs
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