NCT02312609

Bioequivalence Study of Minocycline HCl 135 mg ER Tablet Sunder Fed Conditions

An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single-dose, Crossover, Bioequivalence Study Comparing Minocycline Hydrochloride 135 mg Extended Release Tablets (Containing Minocycline Hydrochloride 135 mg) of OHM Laboratories, USA. (A Subsidiary of Ranbaxy Pharmaceuticals Inc., USA) With SolodynTM Extended Release Tablets (Containing Minocycline Hydrochloride 135 mg) of AAI Pharma, Inc. in Healthy, Adult, Male, Human Subjects Under Fed Condition

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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, human, male subjects under fed conditions.

Detailed description

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 high-fat high-calorie breakfast was served to the study subjects. Thirty minutes after start of this breakfast, a single oral dose of minocycline hydrochloride extended release tablet 135 mg of either test or reference investigational product 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Minocycline hydrochloride	extended release tablets 135 mg

Timeline

• Start date: 2008-09-01
• Primary completion: 2008-09-01
• Completion: 2008-12-01
• First posted: 2014-12-09
• Last updated: 2014-12-09