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The DDI Study of SP2086 and Simvastatin

Hengrui Medicine logo

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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