The DDI Study of SP2086 and Valsartan

Phase 1

• Conditions: Type 2 Diabetes
• Interventions: Drug: SP2086; Drug: Valsartan

• Registration Number: NCT02817217
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-01
• Study Start: 2016-03
• Study First Submitted: 2016-06-27
• Study First Submitted QC: 2016-06-28
• Last Update Submitted: 2016-06-28
• Study First Posted: 2016-06-29
• Last Update Posted: 2016-06-29
• Primary Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SP2086 and Valsartan	SP2086	-
SP2086 and Valsartan	Valsartan	-

Primary Outcome Measures

Name	Time	Method
The area under the plasma concentration-time curve (AUC) of SP2086 acid	up to Day 9	AUC (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of Valsartan.
The area under the plasma concentration-time curve (AUC) of Valsartan	up to Day 9	AUC (a measure of the body's exposure to Valsartan) will be compared before and after administration of multiple doses of SP2086
The maximum plasma concentration (Cmax) of SP2086	up to Day 9	Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of Valsartan
The maximum plasma concentration (Cmax) of SP2086 acid	up to Day 9	Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of Valsartan
The maximum plasma concentration (Cmax) of Valsartan	up to Day 9	Cmax (a measure of the body's exposure to Valsartan) will be compared. before and after administration of multiple doses of SP2086
The area under the plasma concentration-time curve (AUC) of SP2086	up to Day 9	AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of Valsartan.

Secondary Outcome Measures

Name	Time	Method
The number of volunteers with adverse events as a measure of safety and tolerability	up to Day 9

Trial Locations

Locations (1)

People's Liberation Army General Hospital of Chengdu Military Region; 🇨🇳 Chengdu, Sichuan, China