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Minocycline HCl Extended Release Tablets 135 mg Oral Bioequivalence Study

NCT01067001 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 18

Last updated 2010-02-11

No results posted yet for this study

Summary

To determine single-dose oral bioequivalence of Minocycline HCl Extended Release Tablets 135 mg manufactured by Amneal Pharmaceuticals Co.(I)Pvt. Ltd., India and SOLODYN® (minocycline hydrochloride) Extended Release Tablets 135 mg Manufactured for Medicis, The Dermatology Company, Scottsdale, AZ 85256, by Wellspring Pharmaceutical Canada Corp., Oakville, Ontario L6H 1M5 in normal, healthy, adult, human subjects under fasting condition.

Conditions

  • Fasting

Sponsors & Collaborators

  • Amneal Pharmaceuticals Co. India Private Limited

    lead INDUSTRY

Principal Investigators

  • Dr. Nikunj Patel, MD, Pharmacology · Director, CRO

Eligibility

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

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2009-10-31
Completion
2009-11-30

Countries

  • India

Study Locations

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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 NCT01067001 on ClinicalTrials.gov