The Drug-drug Interaction of SHR3824 and Metformin

NCT02354027 | Completed Phase 1

• 1 other identifier: SHR3824-105
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Type 2 Diabetes

Keywords

SHR3824 metformin drug-drug interaction

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

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

  Up tp day 9.

Study Arms (1)

SHR3824 25mg/metformin 1000mg

EXPERIMENTAL

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

Interventions

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

Also known as: Henagliflozin metformin

SHR3824 25mg/metformin 1000mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2015
• First Posted: February 3, 2015
• Study Start: September 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: January 1, 2015
• Last Updated: July 16, 2015

Record last verified: 2015-01