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In vivo genetic pharmacological study of esomeprazole

In vivo genetic pharmacological study of esomeprazole

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900023137
Enrollment
Unknown
Registered
2019-05-13
Start date
2016-11-15
Completion date
Unknown
Last updated
2019-05-20

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

Conditions

Healthy subjects

Interventions

Case series:genotype

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 between 18 and 40, including boundary value;The age difference of the same batch shall not exceed 10 years; 2. if the body weight is more than 50 kg, the body mass index (BMI) of the subject is between 19 kg/m2 and 24 kg/m2, including the boundary value. The difference in body weight of the same batch should not be too large. 3. the subject is willing to participate in the test voluntarily and perform the test in accordance with the procedures specified in this test; 4. sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. patients with diseases of clinical significance or who have received surgery within 4 weeks before the trial; 2. there is any abnormality with clinical significance in the results of laboratory examination; 3. have used drugs with known damage to certain organs within 3 months or are currently using drugs; 4. have a history of drug allergy and high sensitivity to environmental substances; 5. susceptible to hypokalemia; 6. congestive heart failure, gastric ulcer, deficiency of glucose-6-phosphate dehydrogenase (G6PD), severe liver function impairment, and severe renal function impairment; 7. patients with a history of any other serious clinical diseases or diseases of cardiovascular system, endocrine system, nervous system or lung, hematology, immunology, psychiatric diseases and metabolic abnormalities; 8. those with recent colds; 9. patients with active bleeding, diabetes, glaucoma and other diseases; 10. HIV-positive persons; 11. hepatitis B surface antigen test positive or hepatitis C test positive; 12. an accompanying therapist of any medical significance is being performed; 13. patients with concomitant medication within 14 days prior to participating in this study; 14. have a history of drug abuse; 15. soft drugs (e.g. cannabis) taken 3 months before and during the study, or hard drugs (e.g. cocaine, benzodiazepine, etc.) taken 1 year before and during the study; 16. those who have participated in other drug trials within 3 months; 17. blood donors within 3 months before the test; 18. patients with coagulopathy or thromboembolic disease. 19. people with cold stomachs. 20. With history of drug allergy; 21. With smoke and alcoholic habits; 22. abnormal findings in physical examination.

Design outcomes

Primary

MeasureTime frame
medicine generation power curve;

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