The DDI Study of SP2086 and Simvastatin

Jiangsu HengRui Medicine Co., Ltd.24 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes

Interventions

SP2086DRUG

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.

SimvastatinDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

the First Hosital of Jilin University

Changchun, Jilin, China

RECRUITING

Outcomes

Primary Outcomes

The maximum plasma concentration (Cmax) of SP2086

Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of Simvastatin.

Time frame: up to Day 9

The maximum plasma concentration (Cmax) of SP2086 acid

Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of Simvastatin.

Time frame: up to Day 9

The maximum plasma concentration (Cmax) of Simvastatin

Cmax (a measure of the body's exposure to Simvastatin) will be compared. before and after administration of multiple doses of SP2086

Time frame: up to Day 9

The area under the plasma concentration-time curve (AUC) of SP2086

AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of Simvastatin.

Time frame: up to Day 9

The area under the plasma concentration-time curve (AUC) of SP2086 acid

AUC (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of Simvastatin.

Time frame: up to Day 9

The area under the plasma concentration-time curve (AUC) of Simvastatin

AUC (a measure of the body's exposure to Simvastatin) will be compared before and after administration of multiple doses of SP2086.

Time frame: up to Day 9

Secondary Outcomes

The number of volunteers with adverse events as a measure of safety and tolerability

Data from ClinicalTrials.gov

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