Clinical Trial to Evaluate Pharmacokinetic Characteristics of Belion in Healthy Subjects

NCT01897428 Phase 1 COMPLETED

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.

Details

Lead sponsor	Korea University Anam Hospital
Phase	Phase 1
Status	COMPLETED
Enrolment	26
Start date	2011-04
Completion	2011-08

Conditions

• Allergic Rhinitis
• Urticaria
• Pruritus

Interventions

• Test-Bepotastine salicylate 9.64 mg
• Reference-bepotastine besilate 10 mg

Primary outcomes

• bepotastine pharmacokinetics: peak plasma concentrations (Cmax) — 24 hr
• Bepotastine Pharmacokinetics: Area under the time vs. plasma concentration curve from 0 to 24 hr(AUCall) — 24 hr
• Bepotastine Pharmacokinetics: Area under the time vs. plasma concentration curve from 0 to infinity(AUCinf) — 24 hr

Countries

South Korea