The Drug-drug Interaction of SP2086 and Metformin

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

This is an open single and self-control study,planning to recruit 24 cases of healthy male volunteers.In the study,subjects were given SP2086 and metformin,and collects blood samples before and after medcine.The purpose is to evaluate the drug interaction between SP2086 and Metformin.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 19 and 26 kg/m2,weight among of 50-100kg.

• willing to using contraception during the study and after the 6 months.

Exclusion Criteria:

• History of diabetes

• History of heart failure or renal insufficiency

• Urinary tract infections, or vulvovaginal mycotic infections

• History of or current clinically significant medical illness as determined by the Investigator

• History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose

• Known allergy to SP2086 or metformin or any of the excipients of the formulation of SP2086 or metformin