The Drug-drug Interaction of SP2086 and Metformin

• ClinicalTrials.gov Identifier: NCT02813863
• Recruitment Status: Completed
• First Posted: June 27, 2016
• Last Update Posted: June 27, 2016
• Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Information provided by (Responsible Party): Jiangsu HengRui Medicine Co., Ltd.

Tracking Information

• First Submitted Date: June 23, 2016
• First Posted Date: June 27, 2016
• Last Update Posted Date: June 27, 2016
• Study Start Date: December 2015
• Actual Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 24, 2016)

• The maximum plasma concentration (Cmax) of SP2086 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (submitted: June 24, 2016): The number of volunteers with adverse events as a measure of safety and tolerability [ Time Frame: up to Day 9 ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Drug-drug Interaction of SP2086 and Metformin
• Official Title: Not Provided
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Type 2 Diabetes

Intervention

• Drug: SP2086
• Drug: Metformin

Study Arms

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.

Interventions:

• Drug: SP2086
• Drug: Metformin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 24, 2016): 24
• Original Actual Enrollment: Same as current
• Study Completion Date: Not Provided
• Actual Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02813863
• Other Study ID Numbers: SP2086-104
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
• Study Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Jiangsu HengRui Medicine Co., Ltd.
• Verification Date: December 2015