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Bioequivalence study of Levetiracetam Tablets in Healthy Chinese Volunteers

Bioequivalence study of Levetiracetam Tablets in Healthy Chinese Volunteers

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800015004
Enrollment
Unknown
Registered
2018-02-27
Start date
2018-01-09
Completion date
Unknown
Last updated
2018-03-05

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

Conditions

Healthy Volunteers

Interventions

J:RT in fasted states
Y:TR in fasted states
B:RT in fed states
D:TR in fed states

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Chinese volunteers aged 18 to 45 years with body mass index (BMI) between 19 and 26 kg/m2 were eligible for participation. Each volunteer was required to provide written informed consent for participation before the study.

Exclusion criteria

Exclusion criteria: Exclusion criteria included known hypersensitivity to any ingredient in this tablet; the presence of heart, kidney, neurologic, or metabolic disease; any acute or chronic disease; and the use of other drugs within 14 days before or during the trial.

Design outcomes

Primary

MeasureTime frame
Cmax;Tmax;AUC0-t;AUC0-8;t1/2;—

Countries

China

Contacts

Public ContactShentu Jianzhong

First Affiliated Hospita, College of Medicine, Zhejiang University

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

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026