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Pharmacokinetics and Tolerability of Intravenous ibuprofen Injection in Healthy Chinese Volunteers: A Randomized, Open-Label, Single- and Multiple-Dose Study

Pharmacokinetics and Tolerability of Intravenous ibuprofen Injection in Healthy Chinese Volunteers: A Randomized, Open-Label, Single- and Multiple-Dose Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-14005725
Enrollment
Unknown
Registered
2014-12-19
Start date
2014-12-19
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

Group A:Treatment sequence:0.2mg0.4mg0.8mg
Group B:Treatment sequence:0.4mg0.8mg0.2mg
Group C:Treatment sequence:0.8mg0.2mg0.4mg
Multiple dose:0.4 g ibuprofen every 6 hours for 2 consecutive days

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 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
AUC0-t;AUC0-infinitely great;t1/2z;CLz/F;Vz/F;AUCss;Css_max;Css_min;Cav;DF;—

Countries

China

Contacts

Public ContactJianzhong Shentu
stjz@zju.edu.cn+86 0571-87236560

Outcome results

None listed

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