- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02817243
The DDI Study of SP2086 and Simvastatin
June 28, 2016 updated by: Jiangsu HengRui Medicine Co., Ltd.
The Drug Interaction Study of SP2086 and Simvastatin in Healthy Subjects
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.
Study Overview
Detailed 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.
Study Type
Interventional
Enrollment (Anticipated)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jilin
-
Changchun, Jilin, China
- Recruiting
- the First Hosital of Jilin University
-
Contact:
- Yanhua Ding, docter
- Phone Number: 0431-88782168
- Email: dingyanhua2003@126.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: SP2086 and 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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The maximum plasma concentration (Cmax) of SP2086
Time Frame: 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 Simvastatin.
|
up to Day 9
|
The maximum plasma concentration (Cmax) of SP2086 acid
Time Frame: 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 Simvastatin.
|
up to Day 9
|
The maximum plasma concentration (Cmax) of Simvastatin
Time Frame: up to Day 9
|
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
|
The area under the plasma concentration-time curve (AUC) of SP2086
Time Frame: 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 Simvastatin.
|
up to Day 9
|
The area under the plasma concentration-time curve (AUC) of SP2086 acid
Time Frame: 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 Simvastatin.
|
up to Day 9
|
The area under the plasma concentration-time curve (AUC) of Simvastatin
Time Frame: up to Day 9
|
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
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The number of volunteers with adverse events as a measure of safety and tolerability
Time Frame: up to Day 9
|
up to Day 9
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2016
Primary Completion (Anticipated)
July 1, 2016
Study Registration Dates
First Submitted
June 27, 2016
First Submitted That Met QC Criteria
June 28, 2016
First Posted (Estimate)
June 29, 2016
Study Record Updates
Last Update Posted (Estimate)
June 29, 2016
Last Update Submitted That Met QC Criteria
June 28, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SP2086-112
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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