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Comparative Fasting Bioavailability of Two Cycloserine Formulations in Healthy Male Chinese Volunteers: An Open-Label, Randomized, Single-Dose, Two-Way Crossover Study

Comparative Fasting Bioavailability of Two Cycloserine 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-13003981
Enrollment
Unknown
Registered
2013-12-11
Start date
2010-11-30
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:Zhejiang Hisun Pharmaceutical CO.,LTD products Cycloserine 500 mg
B:Refencece 500 mg

Sponsors

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

Eligibility

Sex/Gender
Male
Age
18 Years to 40 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. 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;AUC0-t;AUC0-8;t1/2z;Tmax;CL;90%Confidence Interval;relative bioavailability;—

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: Feb 4, 2026