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

Clinical Trial to Evaluate Pharmacokinetic Characteristics of Belion in Healthy Subjects

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.

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