The DDI Study of SP2086 and Simvastatin

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Simvastatin

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 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