The Drug-drug Interaction of SP2086 and Metformin

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: SP2086; Drug: Metformin

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SP2086 and 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.	Drug: SP2086; Drug: Metformin

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
The number of volunteers with adverse events as a measure of safety and tolerability	up to Day 9

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: June 23, 2016
• First Submitted That Met QC Criteria: June 24, 2016
• First Posted (Estimate): June 27, 2016

Study Record Updates

• Last Update Posted (Estimate): June 27, 2016
• Last Update Submitted That Met QC Criteria: June 24, 2016
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: SP2086-104