The Drug-drug Interaction of SP2086 and Metformin

Type 2 Diabetes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02813863
• Other study ID #: SP2086-104
• Status: Completed
• Phase: Phase 1
• First received: June 23, 2016
• Last updated: June 24, 2016
• Start date: December 2015

Study information

• Verified date: December 2015
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• SP2086

• Metformin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	The number of volunteers with adverse events as a measure of safety and tolerability		up to Day 9	Yes