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The Drug-drug Interaction of SP2086 and Metformin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02813863
Recruitment Status : Completed
First Posted : June 27, 2016
Last Update Posted : June 27, 2016
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Tracking Information
First Submitted Date  ICMJE June 23, 2016
First Posted Date  ICMJE June 27, 2016
Last Update Posted Date June 27, 2016
Study Start Date  ICMJE December 2015
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Drug-drug Interaction of SP2086 and Metformin
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE
  • Drug: SP2086
  • Drug: Metformin
Study Arms  ICMJE 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 24, 2016)
24
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02813863
Other Study ID Numbers  ICMJE SP2086-104
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jiangsu HengRui Medicine Co., Ltd.
Study Sponsor  ICMJE Jiangsu HengRui Medicine Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Jiangsu HengRui Medicine Co., Ltd.
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP