- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02500485
The Drug-drug Interaction of SHR3824 and SP2086
November 23, 2015 updated by: Jiangsu HengRui Medicine Co., Ltd.
Drug Interaction Study of Henagliflozin and Retagliptin in Healthy Subjects
The purpose of the study is to investigate the potential interaction between multiple oral doses of SHR3824 and multiple oral doses of SP2086 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 SHR3824 and SP2086 in healthy adult volunteers.
SHR3824(a Sodium-Glucose Cotransporter 2 inhibitor) is currently under development to lower blood sugar levels in patients with type 2 diabetes mellitus (T2DM) ,and SP2086(a Dipeptidyl peptidase IV inhibitor) is also currently under development to lower blood sugar levels in patients with type 2 diabetes mellitus (T2DM).SP2086 will be administered orally (by mouth) as 100mg on Days 1, 2, 3, 4, 15, 16, 17 and 18, SHR3824 will be administered orally (by mouth) as 20mg on Days 11, 12, 13, 14, 15, 16, 17 and 18.
Both SHR3824 and SP2086 tablets will be taken with 8 ounces (240 mL) of water.
Study Type
Interventional
Enrollment (Anticipated)
12
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 Contact
- Name: Haiyan Liu, PhD
- Phone Number: +86-15705155025
- Email: liuhaiyan@shhrp.com
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China
- Recruiting
- Phase I Unit of Tongji Hospital affilated Tongji Medical School of Huangzhong Science and Thechnology
-
Contact:
- Dong Liu, PhD
-
-
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
No
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 24 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 SHR3824 or SP2086 or any of the excipients of the formulation of SHR3824 or SP2086
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 |
---|---|
Experimental: SHR3824 20mg/SP2086 100mg
One 100-mg tablet of SP2086 once daily on Day 1,2,3,4 followed by two 10-mg tablets of SHR3824 once daily on Day 11,12,13,14, followed by one 100-mg tablet of SP2086 and two 10-mg tablets of SHR3824 on Day 15,16,17,18.
|
One 100-mg tablet of SP2086 once daily on Day 1,2,3,4 followed by two 10-mg tablets of SHR3824 once daily on Day 11,12,13,14, followed by one 100-mg tablet of SP2086 and two 10-mg tablets of SHR3824 on Day 15,16,17,18.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The maximum plasma concentration (Cmax) of SHR3824.
Time Frame: At protocol-specified times up to Day 14 and Day 18.
|
Cmax (a measure of the body's exposure to SHR3824) will be compared before and after administration of multiple doses of SP2086.
|
At protocol-specified times up to Day 14 and Day 18.
|
The area under the plasma concentration-time curve (AUC) of SHR3824.
Time Frame: At protocol-specified times up to Day 14 and Day 18.
|
AUC (a measure of the body's exposure to SHR3824) will be compared before and after administration of multiple doses of SP2086.
|
At protocol-specified times up to Day 14 and Day 18.
|
The maximum plasma concentration (Cmax) of SP2086.
Time Frame: At protocol-specified times up to Day 4 and Day 18.
|
Cmax (a measure of the body's exposure to SP2086) will be compared.
before and after administration of multiple doses of SHR3824
|
At protocol-specified times up to Day 4 and Day 18.
|
The area under the plasma concentration-time curve (AUC) of SP2086.
Time Frame: At protocol-specified times up to Day 4 and Day 18.
|
AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of multiple doses of SHR3824.
|
At protocol-specified times up to Day 4 and Day 18.
|
The number of volunteers with adverse events as a measure of safety and tolerability.
Time Frame: Up tp day 18.
|
Up tp day 18.
|
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
May 1, 2015
Primary Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
July 14, 2015
First Submitted That Met QC Criteria
July 14, 2015
First Posted (Estimate)
July 16, 2015
Study Record Updates
Last Update Posted (Estimate)
November 25, 2015
Last Update Submitted That Met QC Criteria
November 23, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SHR3824-106
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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