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Minocycline HCl Extended Release Tablets 135 mg Oral Bioequivalence Study

2014-08-27 03:16:00 | BioPortfolio

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.

Description

Subjects will be fasted for at least 10 hours prior to scheduled time for dosing. As per the randomization schedule, one tablet of test or reference product will be administered to each subject with 240 mL of water at ambient temperature in each period.

Twenty four samples will be collected from each subject during each period. The venous blood samples (5 mL each) will be withdrawn at pre-dose (before dosing, in the morning of the day of dosing) and at 1.00, 2.00, 2.50, 3.00, 3.25, 3.50, 3.75, 4.00, 4.25, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 48.00, 72.00, 96.00, and 120.00 hours after dosing. The samples collected at 48.00, 72.00, 96.00, and 120.00 hours after dosing will be on an ambulatory basis (i.e. on separate visit).

After collecting the blood samples from all the subjects at each sampling time point, samples will be centrifuged under refrigeration with machine set at 3000 rpm, 10 minutes and 4oC. After centrifugation, the plasma samples will be separated and transferred into respective prelabeled polypropylene tubes. These polypropylene tubes will be stored below -20°C for a maximum period of 12 hours and then they will be stored at -70°C ± 20°C until withdrawn for analysis.

Samples from all the subjects completing both periods of the study as per the approved protocol will be analyzed.

Study Design

N/A

Conditions

Fasting

Location

Hyderabad
Andharapradesh
India

Status

Completed

Source

Amneal Pharmaceuticals Co. India Private Limited

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:00-0400

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An autosomal recessive fructose metabolism disorder due to absent or deficient fructose-1,6-diphosphatase activity. Gluconeogenesis is impaired, resulting in accumulation of gluconeogenic precursors (e.g., amino acids, lactate, ketones) and manifested as hypoglycemia, ketosis, and lactic acidosis. Episodes in the newborn infant are often lethal. Later episodes are often brought on by fasting and febrile infections. As patients age through early childhood, tolerance to fasting improves and development becomes normal.

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