Bioequivalence of Gliclazide Tablets (Fasting) in the Human Body

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-IIC-16008348
• Date of registration: 2016-04-23
• Prospective Registration: Yes
• Primary sponsor: Institute of Clinical Pharmacy, Central South University
• Public title: Bioequivalence of Gliclazide Tablets (Fasting) in the Human Body
• Scientific title: Bioequivalence of Gliclazide Tablets (Fasting) in the Human Body
• Date of first enrolment: 2016-04-24
• Target sample size: 1:10;2:10;1:10;2:10;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=14122
• Study type: Interventional study
• Study design: Cross-sectional
• Phase: I (Phase I study)

Countries of recruitment

China

Contacts

• Name: Zhang Bikui
• Affiliation: Institute of Clinical Pharmacy, Central South University

• Name: Wu Yanqin
• Affiliation: Institute of Clinical Pharmacy, Central South University

Key inclusion & exclusion criteria

Inclusion criteria: 1. Gender: male and female;
2. Age: 18~40 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: 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.

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Pharmacokinetics and Bioequivalence Study in human

Intervention(s)

1:Group One received the trial preparation at the first period;2:Group two received the reference preparation at the first period;1:Group One received the reference preparation at the second period;2:Group two received the trial preparation at the second period;

Primary Outcome(s)

plasma concentration of Gliclazide;

Source(s) of Monetary Support

Synco Limited,Hong Kong