Clinical Trial to Evaluate Pharmacokinetic Characteristics of Belion in Healthy Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- bepotastine pharmacokinetics: peak plasma concentrations (Cmax)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Reference arm
Treated with Reference (bepotastine besilate 10 mg)
Intervention: Reference-bepotastine besilate 10 mg (Drug)
Test arm
Treated with Test (bepotastine salicylate 9.64 mg)
Intervention: Test-Bepotastine salicylate 9.64 mg (Drug)
Outcomes
Primary Outcomes
bepotastine pharmacokinetics: peak plasma concentrations (Cmax)
Time Frame: 24 hr
Bepotastine Pharmacokinetics: Area under the time vs. plasma concentration curve from 0 to 24 hr(AUCall)
Time Frame: 24 hr
Bepotastine Pharmacokinetics: Area under the time vs. plasma concentration curve from 0 to infinity(AUCinf)
Time Frame: 24 hr
Secondary Outcomes
No secondary outcomes reported
Investigators
Ji-Young Park
Associate Professor of Clinical Pharmacology
Korea University Anam Hospital