The Drug-drug Interaction of SHR3824 and SP2086

Hengrui Medicine

Status and phase: Unknown; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: SHR3824, SP2086

Study type: Interventional

Funder types: Industry

Identifiers

NCT02500485

SHR3824-106

Details and patient eligibility

About

The purpose of the study is to investigate the potential interaction between multiple oral doses of SHR3824 and multiple oral doses of SP2086 in healthy adult volunteers.

Full description

This is an open-label (volunteers will know the names of treatments they are assigned) single-center study of SHR3824 and SP2086 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 SP2086(a Dipeptidyl peptidase IV inhibitor) is also currently under development to lower blood sugar levels in patients with type 2 diabetes mellitus (T2DM).SP2086 will be administered orally (by mouth) as 100mg on Days 1, 2, 3, 4, 15, 16, 17 and 18, SHR3824 will be administered orally (by mouth) as 20mg on Days 11, 12, 13, 14, 15, 16, 17 and 18. Both SHR3824 and SP2086 tablets will be taken with 8 ounces (240 mL) of water.

Enrollment: 12 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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 SP2086 or any of the excipients of the formulation of SHR3824 or SP2086

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

SHR3824 20mg/SP2086 100mg

Experimental group

Description:

One 100-mg tablet of SP2086 once daily on Day 1,2,3,4 followed by two 10-mg tablets of SHR3824 once daily on Day 11,12,13,14, followed by one 100-mg tablet of SP2086 and two 10-mg tablets of SHR3824 on Day 15,16,17,18.

Treatment:

Drug: SHR3824, SP2086