The Drug-drug Interaction of SHR3824 and Metformin

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Drug Interaction Study of Henagliflozin and Metformin in Healthy Subjects

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: SHR3824 metformin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHR3824 25mg/metformin 1000mg<br>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<br>* 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<br>* Other names: Henagliflozin metformin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The maximum plasma concentration (Cmax) of SHR3824. | Cmax (a measure of the body's exposure to SHR3824) will be compared before and after administration of a single dose of metformin. | At protocol-specified times up to Day 9. | 
| The area under the plasma concentration-time curve (AUC) of SHR3824. | AUC (a measure of the body's exposure to SHR3824) will be compared before and after administration of a single dose of metformin. | At protocol-specified times up to Day 9. | 
| The maximum plasma concentration (Cmax) of metformin. | Cmax (a measure of the body's exposure to metformin) will be compared. before and after administration of multiple doses of SHR3824 | At protocol-specified times up to Day 9. | 
| The area under the plasma concentration-time curve (AUC) of metformin | AUC (a measure of the body's exposure to metformin) will be compared before and after administration of multiple doses of SHR3824. | At protocol-specified times up to Day 9. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of volunteers with adverse events as a measure of safety and tolerability. |  | Up tp day 9. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SHR3824 metformin drug-drug interaction