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Bioequivalence of Amisulpride Tablets (Fasting ) in the Human Body

Bioequivalence of Amisulpride Tablets (Fasting ) in the Human Body

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15007216
Enrollment
Unknown
Registered
2015-10-08
Start date
2015-10-08
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

Pharmacokinetics

Interventions

None listed

Sponsors

Institute of Clinical Pharmacy, Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1. Gender: male and female; 2. Age: 18~35 years, with the age difference less than 10 years; 3. Body weight: Body Mass Index (BMI)=weight (kg)/height (m)2. BMI in this test was within 19~24; 4. Health: Pass general physical examination and blood routine tests, normal liver and kidney functions; 5. Medical History: Subjects with no cardiovascular diseases, no liver or kidney diseases, no diseases in the digestive tract and the mental system; with no drug allergies, no drug dependence, and no postural hypotension; 6. Subjects did not take any other drugs at least two weeks before the trial. 7. Non-smokers and non-drinkers; 8. All subjects are voluntary to take part in the trial and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Abnormalities in general physical examination or laboratory tests; 2. History of cardiovascular, haematological, hepatic, renal, biliary, gastrointestinal, psychological and other acute diseases; drug allergies, drug dependence, and postural hypotension; 3. AIDS and HIV positive; 4. Drug abusers; 5. Subjects in any clinical drug study within two months before the study; 6. Smokers or alcohol consumers; 7. Treatment of other drugs within two weeks before the start of the study.

Design outcomes

Primary

MeasureTime frame
plasma concentration of Amisulpride;

Countries

China

Contacts

Public ContactZhang Bikui
bikui_zh@126.com+86 13973116871

Outcome results

None listed

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