The DDI Study of SP2086 and Valsartan

Jiangsu HengRui Medicine Co., Ltd.24 enrolled

Overview

The purpose of the study is to investigate the potential PK interaction between SP2086 and Valsartan after multiple oral doses treatment in healthy male volunteers.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes

Interventions

SP2086DRUG

SP2086 will be administered orally (by mouth) as 100mg on Days 4, 5, 6, 7, and 8 and Valsartan will be administered orally as two 80mg tablets on Days 1 and 8. Both SP2086 and Valsartan tablets will be taken with 8 ounces (240 mL) of water.

ValsartanDRUG

SP2086 will be administered orally (by mouth) as100mg on Days 4, 5, 6, 7, and 8 and Valsartan will be administered orally as two 80mg tablets on Days 1 and 8. Both SP2086 and Valsartan tablets will be taken with 8 ounces (240 mL) of water.

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 Valsartan or any of the excipients of the formulation of SP2086 or Valsartan

Locations (1)

People's Liberation Army General Hospital of Chengdu Military Region

Chengdu, Sichuan, 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 Valsartan

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 Valsartan

Time frame: up to Day 9

The maximum plasma concentration (Cmax) of Valsartan

Cmax (a measure of the body's exposure to Valsartan) 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 Valsartan.

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 Valsartan.

Time frame: up to Day 9

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

AUC (a measure of the body's exposure to Valsartan) 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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