Drug-drug Interaction Between Simvastatin and SHR3824

Hengrui Medicine

Status and phase: Unknown; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: SHR3824, Simvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03329118

SHR3824-111

Details and patient eligibility

About

the purpose of thr study is to investigate the potential interation between multiple oral doses of SHR3824 and single oral dose of Simvastatin in healthy adult volunteers.

Enrollment: 12 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male 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 hypoglycemia
• History of urinary tract infections,or genital infections
• History of current clinically significant medical illness as determined by the Investigator
• Known allergy to SHR3824 or Simvastatin or any of the excipients of the formulation of SHR3824 or Simvastatin

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 1Omg,Simavastatin 40mg

Experimental group

Description:

two 20mg tablets of simvastatin once daily on Day 1 followed by one 10mg tablet of SHR3824 once daily on Day 4,5,6,7,followed by two 20mg tablets of simvastatin and one 10mg tablet of SHR3824 on Day 8.

Treatment:

Drug: SHR3824, Simvastatin