The DDI Study of SP2086 and Valsartan

Type 2 Diabetes Clinical Trial

Official title:

The Drug Interaction Study of SP2086 and Valsartan in Healthy Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02817217
• Other study ID #: SP2086-111
• Status: Recruiting
• Phase: Phase 1
• First received: June 27, 2016
• Last updated: June 28, 2016
• Start date: March 2016

Study information

• Verified date: January 2016
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• SP2086
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.
• Valsartan
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.

Locations

Country	Name	City	State
China	People's Liberation Army General Hospital of Chengdu Military Region	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to Day 9	No
Primary	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	up to Day 9	No
Primary	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	up to Day 9	No
Primary	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.	up to Day 9	No
Primary	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.	up to Day 9	No
Primary	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	up to Day 9	No
Secondary	The number of volunteers with adverse events as a measure of safety and tolerability		up to Day 9	Yes