Bioequivalence study of Metformin Hydrochloride osmotic pump control-released Tablets to Chinese volunteers fasting and Fed, randomised, two-way crossover study

• Register: ChiCTR
• Last refreshed on: 22 May 2017
• Main ID: ChiCTR-IIR-17011337
• Date of registration: 2017-05-09
• Prospective Registration: Yes
• Primary sponsor: Beijing Shijitan Hospital Capital Medical University
• Public title: Bioequivalence study of Metformin Hydrochloride osmotic pump control-released Tablets to Chinese volunteers fasting and Fed, randomised, two-way crossover study
• Scientific title: Bioequivalence study of Metformin Hydrochloride osmotic pump control-released Tablets to Chinese volunteers fasting and Fed, randomised, two-way crossover study
• Date of first enrolment: 2017-05-25
• Target sample size: Fasting Group 1:16;Fasting Group 2:16;Fed Group 1:12;Fed Group 2:12;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=19316
• Study type: Interventional study
• Study design: Randomized cross-over control
• Phase: I (Phase I study)

Countries of recruitment

China

Contacts

• Name: Lu Qi
• Affiliation: Beijing Shijitan Hospital Capital Medical University

• Name: Xinghe Wang
• Affiliation: Beijing Shijitan Hospital Capital Medical University

Key inclusion & exclusion criteria

Inclusion criteria: 1. Chinese healthy subjects, gender parity;
2. Aged older than 18 years old;
3. Should be not less than 50 kg weight, body mass index (BMI) 19-28 kg/m2 / BMI = weight/height 2 (including 19 and 28 kg/m2);
4. Health in good condition, not intentional, liver, kidney, gastrointestinal tract, nervous system and history of mental disorder and metabolic abnormalities;
5. Have the ability to communicate with staff normal and in accordance with relevant regulations of the hospital;
6. Test details before the nature, significance, may benefit, inconvenience and potential danger, understand the research program and Voluntarily signed informed consent.
Exclusion criteria: 1. The physical examination, vital signs, abnormal electrocardiogram (ECG) and laboratory examination (to judge by the clinicians have clinical significance);
2. Always have the digestive system disease or a history of digestive surgery (except for appendicitis) affect drug absorption;
3. Have a past history of major disease (spirit of respiratory system, circulatory system and nervous system, etc.), or mental or legal disability;
4. HBsAg test positive or active hepatitis;
5. HIV or TP or hepatitis C antibody test positive;
6. Smoke more than five cigarettes a day, doubt or does history of drug abuse, alcohol intake 3 months more than a day on average two units (1 = 12 ounces or 360 ml beer, 5 ounces, or 150 ml of liquor, 1.5 ounces or 45 ml distilled spirits) or test positive for alcohol; or history of drug or drug abuse;
7. Rounding out the top three months, in another drug test or used the test drug;
8. Test within 30 days before using any drugs inhibit or induce hepatic drug metabolic enzymes;
9. Test used within 2 weeks before any other drugs;
10. Clinically significant history of allergy, especially the history of drug allergy, especially for metformin and allergy to any ingredient in the supplementary material;
11. Three months before the test and offer a blood or blood loss is equal to or more than 500 mL;
12. Pregnant or breastfeeding women, or are pregnant may not acceptable contraceptive methods of women, or pregnancy test positive for and did not take effective contraceptive measures or their spouses program gave birth to six months;
13. Can't tolerate venipuncture blood;
14. Can't guarantee from 48 hours before taking the medicine to the front of the last blood banned smoking and serve grapefruit juice or any food and drinks containing alcohol and xanthine (including chocolate, tea, coffee, coke, etc.);
15. Researcher concludes that the subjects were unable to complete this study, or that the participants involved in this study the other condition that may cause damage.

Age minimum: 18
Age maximum: 50
Gender: Both

Health Condition(s) or Problem(s) studied

diabetes

Intervention(s)

Fasting Group 1:Fasting, Phase 1 for T, Phase 2 for R;Fasting Group 2:Fasting, Phase 1 for R, Phase 2 for T;Fed Group 1:Fed, Phase 1 for T, Phase 2 for R;Fed Group 2:Fed, Phase 1 for R, Phase 2 for T;

Primary Outcome(s)

Pulse;Respiration;Blood Pressure;ECG;Temperature;Blood Routine Examination;Routine Urine Examination;Blood Biochemical;

Source(s) of Monetary Support

Qingdao BAHEAL pharmaceutical Co., LTD