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Completed

NCT Number: NCT02354027

The Drug-drug Interaction of SHR3824 and Metformin

The purpose of the study is to investigate the potential interaction between multiple oral doses of SHR3824 and a single oral dose of metformin in healthy adult volunteers.

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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

About this study

This is an open-label (volunteers will know the names of treatments they are assigned) single-center study of SHR3824 and metformin in healthy adult volunteers. SHR3824(a Sodium-Glucose Cotransporter 2 inhibitor) is currently under development to lower blood sugar levels in patients with type 2 diabetes mellitus (T2DM) and metformin is an approved treatment for patients with T2DM. SHR3824 will be administered orally (by mouth) as 25 mg on Days 4, 5, 6, 7, and 8 and metformin will be administered orally as two 500mg tablets on Days 1 and 8. Both SHR3824 and metformin tablets will be taken with 8 ounces (240 mL) of water.

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 24 kg/m2.

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 SHR3824 or metformin or any of the excipients of the formulation of SHR3824 or metformin

Treatment and study plan

SHR3824 metformin

Drug

Two 500-mg tablets of metformin on Day 1 followed by 25 mg of SHR3824 once daily on Days 4 through 8 followed by two 500-mg tablets of metformin and 25 mg of SHR3824 on Day 8.

Drug: SHR3824 + Metformin

Other names: Henagliflozin metformin

Primary outcomes

  1. The maximum plasma concentration (Cmax) of SHR3824.

    Time frame: At protocol-specified times up to Day 9.

    Cmax (a measure of the body's exposure to SHR3824) will be compared before and after administration of a single dose of metformin.

  2. The area under the plasma concentration-time curve (AUC) of SHR3824.

    Time frame: At protocol-specified times up to Day 9.

    AUC (a measure of the body's exposure to SHR3824) will be compared before and after administration of a single dose of metformin.

  3. The maximum plasma concentration (Cmax) of metformin.

    Time frame: At protocol-specified times 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 SHR3824

  4. The area under the plasma concentration-time curve (AUC) of metformin

    Time frame: At protocol-specified times 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 SHR3824.

Secondary outcomes

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

    Time frame: Up tp day 9.

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

Drug Interaction Study of Henagliflozin and Metformin in Healthy Subjects

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Feb 3, 2015
Registry last updated
Jul 16, 2015

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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