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The Drug-drug Interaction of SHR3824 and Metformin

Information source: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes

Intervention: SHR3824 metformin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Jiangsu HengRui Medicine Co., Ltd.

Summary

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.

Clinical Details

Official title: Drug Interaction Study of Henagliflozin and Metformin in Healthy Subjects

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

The maximum plasma concentration (Cmax) of SHR3824.

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

The maximum plasma concentration (Cmax) of metformin.

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

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

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.

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 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

Locations and Contacts

Additional Information

Starting date: September 2014
Last updated: July 14, 2015

Page last updated: August 23, 2015

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