The Drug-drug Interaction of SP2086 and Metformin

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: SP2086; Drug: Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02813863

SP2086-104

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

SP2086 and Metformin

Experimental group

Description:

In the first day,the subject takes metformin 1000mg once,and from Day 4 to Day 7 they need to take SP2086 100mg everyday. In Day 8,they will be given SP2086 100mg and metformin 1000mg.

Treatment:

Drug: SP2086

Drug: Metformin