NCT00776217

Bioequivalence Study on Loratadine Orally Disintegrating Tablets 10 mg Under Fasting Conditions

An Open Label, Balanced, Randomized, Two-Treatment, Two-Sequence, Two-Period, Single-Dose, Crossover, Bioavailability Study on Loratadine Formulations Comparing Loratadine 10 mg Orally Disintegrating Tablets of Ohm Laboratories, Inc. (A Subsidiary of Ranbaxy Pharmaceuticals Inc) With Claritin® Reditabs 10 mg Tablet (Containing Loratadine 10 mg) of Schering- Plough Healthcare Product Inc, in Healthy, Adult, Male, Human Subjects Under Fasting Condition

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To compare the single-dose oral bioavailability of loratadine 10 mg orally disintegrating tablets of Ohm Laboratories (a subsidiary of Ranbaxy Pharmaceuticals Inc., USA) with Claritin® Reditabs® (containing loratadine 10 mg) of Schering-Plough Healthcare Product Inc., USA in healthy, adult, human male subjects under fasting condition.

Detailed description

The study was conducted as an open label, balanced, randomized, two-treatment, two-sequence, two-period, single-dose, crossover, bioavailability study on loratadine formulation comparing loratadine 10 mg orally disintegrating tablets of Ohm Laboratories, Inc. (a subsidiary of Ranbaxy pharmaceuticals Inc, USA) with Claritin® Reditabs® 10 mg tablet (containing loratadine 10 mg) of Schering- Plough Healthcare Product Inc, in healthy, adult, male, human subjects under fasting condition. A single oral dose of loratadine 10 mg orally disintegrating tablets was orally administered under low light condition during each period of the study under the supervision of a trained Medical Officer. Subjects were instructed to let the tablets completely dissolve on the tongue before swallowing the saliva and then, 240 mL of water was administered 30 seconds after drug administration. During the course of the study safety parameters assessed were vital signs, clinical examination, medical history and clinical laboratory safety tests (hematology, biochemical parameters and urine analysis) at baseline. Laboratory parameters of hematology and biochemistry were repeated at the end of the study. A total of 80 subjects were randomized to receive a single oral dose of the test or reference formulation for loratadine 10 mg. Seventy-four subjects completed both the periods of the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	loratadine 10 mg orally disintegrating tablets

Timeline

• Start date: 2006-06-01
• Primary completion: 2006-07-01
• Completion: 2006-09-01
• First posted: 2008-10-21
• Last updated: 2008-10-21