Minocycline HCl Extended Release Tablets 135 mg Oral Bioequivalence Study (Minocycline)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01067001|
Recruitment Status : Completed
First Posted : February 11, 2010
Last Update Posted : February 11, 2010
|Condition or disease|
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 The venous blood samples (5 mL each) will be withdrawn at pre-dose (before dosing, in the morning of the day of dosing) and at 1.00, 2.00, 2.50, 3.00, 3.25, 3.50, 3.75, 4.00, 4.25, 4.50, 5.00, 5.50, 6.00, 7.00,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tubes will be stored below -20°C for a maximum period of 12 hours and then they will be stored at -70°C ± 20°C until withdrawn for analysis.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 Type :||Observational|
|Actual Enrollment :||18 participants|
|Official Title:||Open Label, Balanced, Randomized, Two-treatment, Two-sequence, Two-period, Single-dose, Crossover, Bioequivalence Study in Normal, Healthy, Adult, Human Subjects Under Fasting Condition.|
|Study Start Date :||September 2009|
|Primary Completion Date :||October 2009|
|Study Completion Date :||November 2009|
2 Way Crossover
2 Way Crossover bioequivalence study
Subjects will be randomly divided in to 2 groups.
A total of 18 normal, healthy, adult, human subjects will be enrolled in the study.
- The following parameters will be considered as primary end points to determine the bioequivalence of test and reference products: Cmax, AUC0-t and AUC0-INF
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01067001
|Hyderabad, Andharapradesh, India|
|Study Director:||Dr. Nikunj Patel, MD, Pharmacology||Director, CRO|