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A Randomized, Double-blinded, Two-way Crossover Bioequivalence Study of Propofol Injection in Healthy Fasted Chinese Male Volunteers

A Randomized, Double-blinded, Two-way Crossover Bioequivalence Study of Propofol Injection in Healthy Fasted Chinese Male Volunteers

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TTRCC-12002260
Enrollment
Unknown
Registered
2012-06-11
Start date
2011-05-30
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

Health men

Interventions

two:dimestic and imported Propofol Injection

Sponsors

The Third Xiangya Hospital, Central South University, Changsha, Hunan
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
19 Years to 27 Years

Inclusion criteria

Inclusion criteria: 1. Healthy participants, aged from 18 to 45 years, BMI 19 to 25 kg/m2; 2. No addiction to alcohol or drugs, non-smokers; 3. Healthy participants confirmed by physical examination, disease history, vital signs, ECG and laboratory tests; with no diseases of heart, liver, kidney, gastrointestinal system, neurological system; with no psychiatric or metabolic disorders; 4. With normal BP, HR, ECG, respiratory rate, liver and kidney function, and blood count; 5. Sign the written informed consent before the study; 6. With sufficient ability to communicate and to fulfill the study.

Exclusion criteria

Exclusion criteria: 1. Allergic to active pharmaceutical ingredients; 2. With gastrointestinal tract diseases; 3. With history of drug abuse within five years; 4. Use of drugs that might cause injury to organs within three months; 5. Use of other drugs within 14 days before the study; 6. Participates in other trials within 3 months; 7. Suffer from severe blood loss within 30 days before the study; 8. With diseases of primary organs; 9. Smokers or alcohol abusers; 10. Addictive to sedative and other drugs; 11. Patients that researchers regard not eligible for inclusion.

Design outcomes

Primary

MeasureTime frame
Plasma propofol concentration;

Countries

China

Contacts

Public ContactZeneng Cheng

Pharmaceutical college of Central South University

chengzenengcsu@yahoo.com.cn+86 13874879386

Outcome results

None listed

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