NCT00776282

Bioequivalence Study of Loratadine Orally Disintegrating Tablets 10 mg Under Fed 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 Fed 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 Inc (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 fed 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, USA. in healthy, adult, male, human subjects under fed condition. A single oral dose of loratadine 10 mg orally disintegrating tablets was administered under low light condition during each period of the study under supervision of a trained medical officer. Subjects were instructed to completely dissolve the tablet 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, serology parameters and urine analysis) at base line. Laboratory parameters of hematology and biochemistry were repeated at the end of the study. A total of 80 subjects were randomized to receive single oral dose of Loratadine 10mg and Subjects were admitted in two groups of equal size. Group I: 1-40 Group II: 41-80 70 subjects completed both the periods of the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	loratadine 10 mg orally disintegrating

Timeline

• Start date: 2006-07-01
• Primary completion: 2006-08-01
• Completion: 2006-09-01
• First posted: 2008-10-21
• Last updated: 2008-10-21