The Drug-drug Interaction of SHR3824 and Metformin

Jiangsu HengRui Medicine Co., Ltd.12 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes

Interventions

SHR3824 metforminDRUG

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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

Time frame: 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.

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

Secondary Outcomes

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

Time frame: Up tp day 9.

Data from ClinicalTrials.gov

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