The Drug-drug Interaction of SHR3824 and Metformin

Drug Interaction Study of Henagliflozin and Metformin in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02354027

Enrollment

Registered

2015-02-03

Start date

2014-09-30

Completion date

2015-01-31

Last updated

2015-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

SHR3824 metformin drug-drug interaction

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.

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.

Interventions

DRUGSHR3824 metformin

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
The maximum plasma concentration (Cmax) of SHR3824.	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.
The area under the plasma concentration-time curve (AUC) of SHR3824.	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.
The maximum plasma concentration (Cmax) of metformin.	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
The area under the plasma concentration-time curve (AUC) of metformin	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

Measure	Time frame
The number of volunteers with adverse events as a measure of safety and tolerability.	Up tp day 9.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026