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

NCT02312297 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2014-12-09

No results posted yet for this study

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, male, human subjects under fasting condition.

Conditions

  • Healthy

Interventions

DRUG

Minocycline hydrochloride

extended release tablets 135 mg

Sponsors & Collaborators

  • Ranbaxy Laboratories Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2008-09-30
Completion
2008-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02312297 on ClinicalTrials.gov