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Pharmacogenomics study on the effects of drug metabolizing enzyme and transporter gene polymorphisms on the pharmacokinetics of gefitinib

Pharmacogenomics study on the effects of drug metabolizing enzyme and transporter gene polymorphisms on the pharmacokinetics of gefitinib

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200058996
Enrollment
Unknown
Registered
2022-04-22
Start date
2022-04-22
Completion date
Unknown
Last updated
2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Oral administration group:Fasting oral gefitinib tablets

Sponsors

Huzhou Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Healthy males aged >=18 years; 2. Weight >=50 kg, body mass index 19-26 kg/m^2; 3. No fertility plan or sperm donation plan within 1 month from the start of the trial to the last dose, and take effective contraceptive measures voluntarily.

Exclusion criteria

Exclusion criteria: 1. Any previous or current clinically serious illness or any other illness that can interfere with the results of the test; 2. A history of allergies to drugs, foods or other substances; 3. Patients who took any medication 14 days before the trial; 4. Use drugs that interfere with drug metabolism 30 days before the test; 5. Smokers and alcoholics; 6. Those who have donated blood or participated in drug trials as subjects within the last 3 months; 7. Patients with clinically significant abnormalities in vital signs, physical examination, electrocardiogram, chest radiograph or various laboratory tests have a clear history of central nervous system, cardiovascular system, kidney, liver, digestive tract, respiratory system, metabolism or skeletal muscle system.

Design outcomes

Primary

MeasureTime frame
Gene polymorphism;

Countries

China

Contacts

Public ContactYang Shuixin

Huzhou Central Hospital

ysx@hzhospital.com+86 13819233850

Outcome results

None listed

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