Administration method of bioequivalence evaluation of hypoglycemic drugs

• Main Authors: ZHOU LIJUAN, LI XINNAN, WU JING
• Format: Patent
• Language: Chinese; English
• Published: 19.03.2019
• Subjects: HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES

The invention provides an administration method of bioequivalence evaluation of hypoglycemic drugs, and relates to an administration method of bioequivalence evaluation by using blood glucose concentration as a pharmacodynamics index. The method comprises three stages, namely an administration buffering stage as the first stage, a sucrose load testing stage as the second stage, and a withdrawal stage as the third stage; in the first administration buffering stage, a subject is administrated in single dosage before three meals every day for consecutive days, and is absolute diet at the dinner of the last day; in the second sucrose load testing stage, the subject is administrated in single dosage after being absolute diet for several hours, and is subjected to high-dosage sucrose load test after several minutes; and in the third withdrawal stage, the subject is not administrated for several days, and is recovered to the level before drug test in the sucrose load test. 本发明提供了种降血糖药物生物等效评价的给药方法，涉及以血糖浓度为药效学指标的生物等效评