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Bioequivalence Evaluation of Dispersible Tablets of Risperidone

Comparative Fasting Bioavailability of Dispersible and Conventional Tablets of Risperidone: A Single-Dose, Randomized- Sequence, Open-Label, Two-Way Crossover Study in Healthy Chinese Male Volunteers

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12001996
Enrollment
Unknown
Registered
2012-03-07
Start date
2009-03-02
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

psychoses

Interventions

test:Oral 2mg the test tablets
reference:Oral 2mg the control tablets

Sponsors

First Affiliated Hospital, College of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
19 Years to 27 Years

Inclusion criteria

Inclusion criteria: (1) Male,Aged from 18 to 40 years old, no more than 10 years in age difference of thee subjects in the same group; (2) BMI ranged from 19 to 25 kg/m2; (3) No history of organic disease and drugallergy; (4) Subjects with normal findings as determined by baseline history, physical examination, vital signs, Haemogram with ESR, Biochemistry, Infectious Disease Screening (HIV,Hepatitis B and Hepatitis C) and Urinalysis, ECG; (5) No drug abuser; (6) No alcoholic and smoking addiction; (7) Good communication with researchers and complied for requirements during the whole research work; (8) given a written informed- consent form and sign on the ICF.

Exclusion criteria

Exclusion criteria: (1) Participated in other clinical research within 3 months; (2) Had a history of blood donation within 1 month or intended to donate blood during the trial; (3) Failed in the general examination, blood pressure, heart rate and breath condition; (4) Any obvious clinical symptoms of disease founded during the medical examination; (5) laboratory evidence of hematology renal cardiac and hepatic abnormity.

Design outcomes

Primary

MeasureTime frame
The plasma concentrations of RIS;

Secondary

MeasureTime frame
The plasma concentrations of 9-OH RIS;

Countries

China

Contacts

Public ContactJianzhong Shen-Tu

First Affiliated Hospital, College of Medicine, Zhejiang University

stjz@zju.edu.cn+86 87236560

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 26, 2026