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The design and evaluation standard of bioequivalence trail of acarbose tablet in Chinese volunteers (two)

The design and evaluation standard of bioequivalence trail of acarbose tablet in Chinese volunteers (two)

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-17013918
Enrollment
Unknown
Registered
2017-12-14
Start date
2017-12-04
Completion date
Unknown
Last updated
2017-12-18

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

Conditions

None listed

Interventions

four groups:different dose of acarbose

Sponsors

The Third Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Aged = 18 years old; 2) Male weight = 50 kg, female = 45 kg, BMI between 19 ~ 26 kg/m2; 3) Willingness and ability to sign informed consent.

Exclusion criteria

Exclusion criteria: 1) any other disease or are currently suffering from previous circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, clinical psychiatry and abnormal metabolism of any serious diseases or can interfere with test results; 2) have allergies to drugs, food or other substances; 3) surgical procedures were performed within 4 weeks of the trial or scheduled for surgery during the study period; 4) anyone who took any medicine (including Chinese herbal medicine) within 14 days before the trial; 5) (interrogation) test in the 30 days before any inhibition or induction of hepatic drug on drug metabolism (such as inducer - barbiturates, phenytoin, C Masi Bing, glucocorticoid, Omeprazole; inhibitor SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles Vera Pammy, sedatives, and fluoroquinolones, antihistamines); 6) taking any clinical trial drug or participating in any clinical trial within 3 months prior to the trial; 7) donors within 3 months before the test; 8) women who are pregnant or lactating, or who cannot take 1 or more contraceptives during the test period; 9) the diet has special requirements, can not comply with the unified diet; 10) drink excessive amounts of tea, coffee and / or caffeinated beverages (8 cups or more, 1 =250 mL) per day; 11) smokers or more than 5 smokers per day for the first 3 months of the test; (12) alcoholics or regular drinkers during the first 6 months of the trial, i.e., drinking more than 14 units of alcohol per week (1 units =360, mL beers or 45 mL alcohol, 40% spirits or 150 mL wines); 13) drug abusers or test 3 months before the use of soft drugs (such as marijuana) or test 1 years before taking hard drugs (such as cocaine, phencyclidine etc.); 14) abnormal vital signs (140 mmHg systolic blood pressure, diastolic blood pressure 90 or mmHg 100 BPM; heart rate) or physical examination, electrocardiogram, drug abuse, alcohol screening test, laboratory abnormalities have clinical significance (according to the clinician's judgment as the standard); 15) glucose tolerance test (OGTT), diagnosed as impaired glucose tolerance. 16) subjects may not be able to complete the study for other reasons or the researchers believe that they should not be included.

Design outcomes

Primary

MeasureTime frame
serum glucose;

Countries

China

Contacts

Public ContactGuoping Yang

The Third Xiangya Hospital of Central South University

ygp9880@126.com+86 13974817168

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 27, 2026