The DDI Study of SP2086 and Simvastatin

Type 2 Diabetes Clinical Trial

Official title:

The Drug Interaction Study of SP2086 and Simvastatin in Healthy Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02817243
• Other study ID #: SP2086-112
• Status: Recruiting
• Phase: Phase 1
• First received: June 27, 2016
• Last updated: June 28, 2016
• Start date: March 2016

Study information

• Verified date: March 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 interaction between multiple oral doses of SP2086 and a single oral dose of Simvastatin in healthy adult volunteers.

Description:

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.

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 metformin or any of the excipients of the formulation of SP2086 or Simvastatin

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 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.
• Simvastatin
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.

Locations

Country	Name	City	State
China	the First Hosital of Jilin University	Changchun	Jilin

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 Simvastatin.	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 Simvastatin.	up to Day 9	No
Primary	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	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 Simvastatin.	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 Simvastatin.	up to Day 9	No
Primary	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.	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