The Drug-drug Interaction of SP2086 and Metformin

NCT02813863 | Completed Phase 1

• 1 other identifier: SP2086-104
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• The number of volunteers with adverse events as a measure of safety and tolerability

  up to Day 9

Study Arms (1)

SP2086 and Metformin

EXPERIMENTAL

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

Interventions

SP2086 DRUG

SP2086 and Metformin

Metformin DRUG

SP2086 and Metformin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2016
• First Posted: June 27, 2016
• Study Start: December 1, 2015
• Primary Completion: March 1, 2016
• Last Updated: June 27, 2016

Record last verified: 2015-12