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
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