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Bioequivalence and Pharmacokinetics of Two Bepotastine Formulations in Healthy Male Chinese Volunteers: An Open-Label, Randomized, Single-Dose, Two-Way Crossover Study

Bioequivalence and Pharmacokinetics of Two Bepotastine Formulations in Healthy Male Chinese Volunteers: An Open-Label, Randomized, Single-Dose, Two-Way Crossover Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TTRCC-13003723
Enrollment
Unknown
Registered
2013-10-08
Start date
2013-07-06
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Interventions

A:a single dose of bepotastine 10-mg reference formulation
B:a single dose of bepotastine 10-mg test formulation

Sponsors

First Affiliated Hospital, College of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
20 Years to 26 Years

Inclusion criteria

Inclusion criteria: Male Chinese volunteers aged 18 to 40 years with body mass index (BMI) between 19 and 25 kg/m2 were eligible for participation

Exclusion criteria

Exclusion criteria: Exclusion criteria included known hypersensitivity to any ingredient in the RIS tablet; a history or evidence of any renal, gastrointestinal, hepatic, or hematologic abnormality; any acute or chronic disease; and the use of other drugs within 14 days before or during the trial.

Design outcomes

Primary

MeasureTime frame
pharmacokinetic parameter;—

Countries

China

Contacts

Public ContactShentu Jianzhong

First Affiliated Hospital, College of Medicine, Zhejiang University

stjz@zju.edu.cn+86 0571-87236560

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 21, 2026