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The Drug-drug Interaction of SP2086 and Metformin

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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.

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: SP2086 Drug: Metformin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2015
Actual Primary Completion Date : March 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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


Secondary Outcome Measures :
  1. The number of volunteers with adverse events as a measure of safety and tolerability [ Time Frame: up to Day 9 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT02813863    
Other Study ID Numbers: SP2086-104
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: June 27, 2016
Last Verified: December 2015
Additional relevant MeSH terms:
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Metformin
Hypoglycemic Agents
Physiological Effects of Drugs