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

Korea University

Status and phase

Completed

Phase 1

Conditions

Allergic Rhinitis

Urticaria

Pruritus

Treatments

Drug: Reference-bepotastine besilate 10 mg

Drug: Test-Bepotastine salicylate 9.64 mg

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01897428

HL-BPT-101

Details and patient eligibility

About

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.

Enrollment

26 patients

Sex

All

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

subjects aged between 20 and 45 years
Body weight > 50 kg (in case of female > 45 kg) with BMI between 18 and 29 kg/m2
Signed and dated informed consent form which meets all criteria of current FDA and KFDA regulations

Exclusion criteria

subjects with acute conditions.
presence of history affecting ADME
Clinically significant history or current evidence of a hepatic, renal, gastrointestinal, or hematologic abnormality
Hepatitis B, hepatitis C, or HIV infection revealed on the laboratory findings
Any other acute or chronic disease
A history of hypersensitivity to bepotastine
A history of alcohol or drug abuse
Participation in another clinical trial within 2 months
smoked >10 cigarettes daily
consumption over 5 glasses daily of beverages containing xanthine derivatives
use of any medication having the potential to affect the study results within 10 days before the start of the study.
medication of the inhibitors or inducers of DME including barbiturates within 1 month
one of abnormal lab findings as like
- c. AST/ALT > UNL (upper normal limit) x 1.5
- Total bilirubin > UNL x 1.5