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Esomeprazole in pharmacogenetic studies

Esomeprazole in pharmacogenetic studies

Status
Recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-BIR-17011016
Enrollment
Unknown
Registered
2017-03-30
Start date
2017-03-31
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 subjects

Interventions

five:esomeprazole

Sponsors

Clinical Pharmacology Institution, Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. healthy volunteers, aged 18 to 40 years, including the boundary value; the same age difference of not more than 10 years of age; 2. weight greater than 50 kg, the subjects of body mass index (BMI) between 19 ~ 24 kg/m2, including the boundary values of the same batch weight difference should not be different; 3. physical examination showed no abnormalities. No history of drug allergy; 4. no history of drug allergy; 5. no smoke, wine hobby; 6. subjects volunteered to participate in the test and to test in accordance with the provisions of the test program; 7. signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. 4 weeks before the trial had a clinically significant disease or had surgery; 2. any laboratory test results are of clinical significance; 3. a drug that is known to have an effect on an organ within 3 months or is currently in use; 4. has a history of drug allergy and is highly sensitive to environmental substances; 5. susceptible to hypokalemia; 6. congestive heart failure, gastric ulcer, glucose -6- phosphate dehydrogenase (G6PD) deficiency, severe liver damage, severe renal impairment; 7. any other history of serious disease or a history of cardiovascular disease, endocrine system, nervous system disease, lung, hematology, immunology, psychiatric disorders, and metabolic disorders; 8. near cold; 9. with active bleeding, diabetes, glaucoma and other diseases; 10. HIV positive test; 11. Hepatitis B surface antigen positive or HCV positive; l2. ongoing treatment with any medical significance; 13. to participate in the trial before the same period with drug users; 14. drug abusers; 15. 3 months prior to the trial and taking soft drugs (e.g. marijuana) during the trial or taking hard drugs such as cocaine, benzene, and so on before and during the trial; 16. participated in other drug trials within 3 months; 17. 3 months before the trial to participate in blood donors; 18. with coagulopathy or thromboembolic disease. 19. stomach cold persons.

Design outcomes

Primary

MeasureTime frame
drug concerntration;

Countries

China

Contacts

Public ContactZhirong Tan

Clinical Pharmacology Institution, Central South University

tanzr@163.com+86 13907496238

Outcome results

None listed

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