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Completed

NCT Number: NCT02813863

The Drug-drug Interaction of SP2086 and Metformin

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SP2086

Drug

metformin

Drug

Primary outcomes

  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 outcomes

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

    Time frame: up to Day 9

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
First posted
Jun 27, 2016
Registry last updated
Jun 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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