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

Phase 1

Completed

• Conditions: Allergic Rhinitis; Urticaria; Pruritus
• Interventions: Drug: Reference-bepotastine besilate 10 mg; Drug: Test-Bepotastine salicylate 9.64 mg

• Registration Number: NCT01897428
• Lead Sponsor: Korea University Anam Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-03
• Study Start: 2011-04
• Primary Completion: 2011-05
• Study Completion: 2011-08
• Study First Submitted: 2013-07-09
• Study First Submitted QC: 2013-07-11
• Last Update Submitted: 2013-07-11
• Study First Posted: 2013-07-12
• Last Update Posted: 2013-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Reference arm	Reference-bepotastine besilate 10 mg	Treated with Reference (bepotastine besilate 10 mg)
Test arm	Test-Bepotastine salicylate 9.64 mg	Treated with Test (bepotastine salicylate 9.64 mg)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dept. of Clinical Pharmacology & Toxicology, Anam Hospital; 🇰🇷 Seoul, Korea, Republic of