The DDI Study of SP2086 and Simvastatin

Hengrui Medicine

Status and phase: Unknown; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: SP2086; Drug: Simvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02817243

SP2086-112

Details and patient eligibility

About

The purpose of the study is to investigate the potential interaction between multiple oral doses of SP2086 and a single oral dose of Simvastatin 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 SP2086 and Simvastatin in healthy adult volunteers. SP2086 will be administered orally (by mouth) as 100 mg on Days 4, 5, 6, 7, and 8 and Simvastatin will be administered orally as two 20mg tablets on Days 1 and 8. Both SP2086 and Simvastatin tablets will be taken with 8 ounces (240 mL) of water.

Enrollment: 24 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 26 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 SP2086 or metformin or any of the excipients of the formulation of SP2086 or Simvastatin

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

SP2086 and Simvastatin

Other group

Description:

SP2086 will be administered orally (by mouth) as 100 mg on Days 4, 5, 6, 7, and 8 and Simvastatin will be administered orally as two 20mg tablets on Days 1 and 8. Both SP2086 and Simvastatin tablets will be taken with 8 ounces (240 mL) of water.

Treatment:

Drug: Simvastatin

Drug: SP2086