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Effects of P450 Oxidoreductase Ala503Val Polymorphism on CYP3A in vivo Activity in Healthy Chinese Male Subjects

Effects of P450 Oxidoreductase Ala503Val Polymorphism on CYP3A in vivo Activity in Healthy Chinese Male Subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-RNC-11001342
Enrollment
Unknown
Registered
2011-05-06
Start date
2010-02-01
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

None listed

Interventions

Sponsors

The Third Xiangya Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
20 Years to 28 Years

Inclusion criteria

Inclusion criteria: 1. Healthy participants, aged from 18 to 40 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
the ratio of AUC of 1-hydroxy midazolam to midazolam;

Countries

China

Contacts

Public ContactGuoping YANG
ygp9880@163.com+86 731 88618339

Outcome results

None listed

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