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

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Korea University Anam Hospital
• Collaborator: Hanlim Pharm. Co., Ltd.
• Treatments: Bepotastine besilate; Salicylates; Salicylic Acid

Criteria

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