The Drug-drug Interaction of SP2086 and Metformin

Phase 1

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: SP2086; Drug: Metformin

• Registration Number: NCT02813863
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-12
• Study Start: 2015-12
• Primary Completion: 2016-03
• Study First Submitted: 2016-06-23
• Study First Submitted QC: 2016-06-24
• Last Update Submitted: 2016-06-24
• Study First Posted: 2016-06-27
• Last Update Posted: 2016-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SP2086 and Metformin	SP2086	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.
SP2086 and Metformin	Metformin	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.

Primary Outcome Measures

Name	Time	Method
The maximum plasma concentration (Cmax) of SP2086	up to Day 9	Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of metformin
The area under the plasma concentration-time curve (AUC) of SP2086	up to Day 9	AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of metformin
The maximum plasma concentration (Cmax) of SP2086 acid	up to Day 9	Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of metformin
The area under the plasma concentration-time curve (AUC) of SP2086 acid	up to Day 9	AUC (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of metformin
The maximum plasma concentration (Cmax) of Metformin	up to Day 9	Cmax (a measure of the body's exposure to metformin) will be compared. before and after administration of multiple doses of SP2086
The area under the plasma concentration-time curve (AUC) of metformin	up to Day 9	AUC (a measure of the body's exposure to metformin) will be compared before and after administration of multiple doses of SP2086

Secondary Outcome Measures

Name	Time	Method
The number of volunteers with adverse events as a measure of safety and tolerability	up to Day 9