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Bioequivalence Study of Minocycline 100mg Tablets Under Fasting Conditions

2014-08-27 03:26:50 | BioPortfolio

Summary

The purpose of this study was to determine the bioequivalence of Minocycline formulations after administration of single doses to normal healthy subjects under fasted conditions. These data were to be evaluated statistically to determine if the products meet bioequivalence criteria.

Description

The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose, crossover , bioequivalence study on minocycline comparing minocycline 100mg tablets of Ranbaxy pharmaceuticals inc with Minocin 100mg capsules of in healthy, adult, human, subjects under fasting conditions.

A total of 28 non-smoking subjects (16 men and 12 women) were included in this study, of which 28 finished the study according to the protocol,

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Conditions

Healthy

Intervention

Minocycline 100mg Tablets

Location

AII pharma
Chapell Hill
North Carolina
United States
27514

Status

Completed

Source

Ranbaxy Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:26:50-0400

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