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Pharmacokinetics of Ifenprodil in Chinese Healthy subjects: A Phase I, Open-Label, Crossover, Single- and Multiple-Dose Study

Pharmacokinetics of Ifenprodil in Chinese Healthy subjects: A Phase I, Open-Label, Crossover, Single- and Multiple-Dose Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TNC-10000910
Enrollment
Unknown
Registered
2010-06-24
Start date
2008-04-01
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

stroke, brain injure, elder dementia, sudden deafness, brain arteriospasm, central embolism of retinal artery, etc.

Interventions

1:Each subject received in random order, single oral dose of 20, 40 or 60 mg ifenprodil tablets in cycle. The interval for washout period of 3 times administration was 7 days.
2:9 Chinese subjects were enrolled in the multiple-dose group of the PK study, and each of them was administered ifenprodil 20 mg orally thrice daily for 6 days.

Sponsors

Southwest Hospital, the Third Military Medical University, China
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
20 Years to 25 Years

Inclusion criteria

Inclusion criteria: (1) Body mass index(BMI) of 19 to 24 kg/m2 (inclusive); (2) No smoking, drinking or drug addiction before or during the study; (3) No history of cardiovascular, renal, gastrointestinal, hepatic, nervous,psychological disease or metabolic disorders.

Exclusion criteria

Exclusion criteria: if they had been enrolled in another pharmacokinetic study, had donated blood or had been given other drugs for some therapeutic courses during the last 3 months; or used caffeine-containing drink within 24 hours before the study.

Design outcomes

Primary

MeasureTime frame
the concentration of ifenprodil in human plasma;

Countries

China

Contacts

Public ContactYongchuan Chen
zwmcyc@163.com+86 23 68765795

Outcome results

None listed

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