Bioequivalence Study of Ondansetron Orally Disintegrating Tablets 8mg Under Fed Conditions
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|ClinicalTrials.gov Identifier: NCT01523119|
Recruitment Status : Completed
First Posted : February 1, 2012
Last Update Posted : February 9, 2012
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Ondansetron||Not Applicable|
The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose, crossover bioavailability study comparing Ondansetron 8 mg orally disintegrating tablets of Ohm Laboratories (A subsidiary of Ranbaxy Pharmaceuticals, USA) with Zofran 8 mg ODT® orally disintegrating tablets (containing 8 mg of ondansetron) manufactured by Cardinal health, UK for GlaxoSmithKline USA, in healthy, adult, human, male subjects under fed condition.
During each period of the study after an overnight fast of at least 10 hours a high-fat high-caloric breakfast was served and 30 minutes after start of high-caloric breakfast, a single oral dose of either test or reference product was administered by placing the tablet on tongue till it dissolved and then swallowed it using 240 mL of drinking water at ambient temperature under supervision of a medical officer.
During the course of the study, safety parameters including vital signs, clinical examination, medical history and clinical laboratory safety tests (hematology, biochemical, serology parameters and urine analysis) were assessed and laboratory parameters of hematology and biochemistry were repeated at the end of the study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, Balanced, Randomised, Two-treatment, Two-period, Two-sequence, Single-dose, Crossover Bioavailability Study Comparing Ondansetron 8 mg Orally Disintegrating Tablets of Ohm Laboratories (A Subsidiary of Ranbaxy Pharmaceuticals USA) With Zofran 8 mg ODT® Orally Disintegrating Tablets (Containing 8 mg of Ondansetron) Manufactured by Cardinal Health, UK for GlaxoSmithKline USA, in Healthy, Adult, Human, Male Subjects Under Fed Condition.|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||July 2006|
|Actual Study Completion Date :||October 2006|
Active Comparator: Zofran ODT
Zofran ODT (Ondansetron) Orally Disintegrating Tablets 8mg Manufactured By Cardinal Health, Blagrove, Swindon, Wiltshire, UK SN58RU
Orally Disintegrating Tablets 8 mg
Experimental: Ondansetron Orally Disintegrating Tablets
Ondansetron Orally Disintegrating Tablets 8 mg Manufactured By Ohm Laboratories Inc (A subsidiary of Ranbaxy Pharmaceuticals, USA)
Orally Disintegrating Tablets 8 mg
- Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of Ondansetron [ Time Frame: 0, 0.333, 0.667, 1, 1.333, 1.667, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 6, 8, 10, 12, 16, 20 and 24 hours. ]
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): NCT01523119
|Clinical Pharmacology Unit, Majeedia Hospital (2nd Floor)|
|New Delhi, India|