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

Allergic Rhinitis Clinical Trial

Official title:

Clinical Trial to Evaluate Pharmacokinetic Characteristics of Belion in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01897428
• Other study ID #: HL-BPT-101
• Status: Completed
• Phase: Phase 1
• First received: July 9, 2013
• Last updated: July 11, 2013
• Start date: April 2011
• Est. completion date: August 2011

Study information

• Verified date: March 2011
• Source: Korea University Anam Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Allergic Rhinitis
• Pruritus
• Urticaria

Intervention

Drug:
• Test-Bepotastine salicylate 9.64 mg

• Reference-bepotastine besilate 10 mg

Locations

Country	Name	City	State
Korea, Republic of	Dept. of Clinical Pharmacology & Toxicology, Anam Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Korea University Anam Hospital	Hanlim Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bepotastine pharmacokinetics: peak plasma concentrations (Cmax)		24 hr	No
Primary	Bepotastine Pharmacokinetics: Area under the time vs. plasma concentration curve from 0 to 24 hr(AUCall)		24 hr	No
Primary	Bepotastine Pharmacokinetics: Area under the time vs. plasma concentration curve from 0 to infinity(AUCinf)		24 hr	No