NCT01897428

PK Comparisons of Bepotastine Besilate 10 mg and Bepotastine Salicylate 9.64 mg

Clinical Trial to Evaluate Pharmacokinetic Characteristics of Belion in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Korea University Anam Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To compare the relative bioavailability and pharmacokinetic characteristics of a newly developed bepotastine formulation, bepotastine salicylate, with a conventional formulation, bepotastine besilate, in healthy subjects with a single dose, randomized, open-label, 2-sequence -2period crossover study.

Conditions

• Allergic Rhinitis
• Urticaria
• Pruritus

Interventions

Type	Name	Description
DRUG	Test-Bepotastine salicylate 9.64 mg
DRUG	Reference-bepotastine besilate 10 mg

Timeline

• Start date: 2011-04-01
• Primary completion: 2011-05-01
• Completion: 2011-08-01
• First posted: 2013-07-12
• Last updated: 2013-07-12

Locations

1 site across 1 country: South Korea