- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02815722
The Drug-drug Interaction of SP2086 and Simvastatin
June 23, 2016 updated by: Jiangsu HengRui Medicine Co., Ltd.
A Single Randomized, Open,Cross-over, Phase Ig Study to Access the Drug-drug Interaction of SP2086 and Simvastatin
The purpose of the study is to investigate the potential interaction between SP2086 and Simvastatin after the multiple oral doses treatment 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 and cross-over study of SP2086 and Simvastatin in healthy adult volunteers.
All subject were randomized into two groups, and the drugs will be administered according to the AB and BA sequences.
The A sequence was that SP2086 was taken at 40mg qd on Day1-Day 10; Simvastatin will be administered orally (by mouth) as 200mg on Day 6-Day10.The B sequence was that Simvastatin was taken at 40mg qd on Day6-Day10.
There were 5 days washout period between A and B. The total time of this trial was 27 days.
Study Type
Interventional
Enrollment (Actual)
16
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
-
-
-
Chengdu, China
- People's Liberation Army General Hospital of Chengdu Military Region
-
-
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
All
Description
Inclusion Criteria:
- Healthy volunteers with a body mass index(BMI) between 19 and 24 Kg/m2
- Had signed the informed consent himself or herself voluntarily.
Exclusion Criteria:
- Have the abnormal lab or other examination results and the change have clinical significance.
- History of or current clinically significant medical illness as determined by the Investigator.
- Have a family history of thyroid cancer, submandibular gland cancer or long QT syndrome
- Known allergy to SP2086 or Glyburide or any of the excipients of the formulation of SP2086 or Glyburide.
- History of using the sulfa or sulfonylureas or DPP-IVor GLP-1 drugs or other similar structure drugs.
- History of severe unconsciousness hypoglycemia
- History of any surgery prior to screening in 6 months.
- History of blood donation≥400 mL prior to screening in 3 months or participate in blood donation,or by blood transfusion in one month.
- History of participate any drug or medical device prior to screening in 3 months.
- Within a month before the screening using any prescription drugs, over-the-counter drugs, Chinese herbal medicine (especially oral antidiabetics drugs) or food supplements( vitamins).
- 2 days before the randomization ,the patients can not ban alcohol, tobacco, or reference food or drink containing caffeine or xanthine , or vigorous exercise, or there are other factors that can affect drug absorption, distribution, metabolism and excretion.
- The hepatitis B surface antigen, hepatitis c antibody, HIV antibody and syphilis antibody was positive.
- Pregnancy or lactation women, or a fertility male or female is not willing to contraception during test.
- Researchers considered that there was any situation that may cause the participants can't finish this study or bring any obvious risk to subjects.
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: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: SP2086 and Simvastatin
All subject were randomized into two groups,and the drugs will be administered according to the AB and BA sequences,all subjects must completed the two stages(A and B).The A sequence was that SP2086 was taken at 200mg qd on Days1-Day10; Simvastatin will be administered orally (by mouth) as 40mg on Days 6-Day10.The B sequence was that Simvastatin was taken at 40mg qd dose on Days 6-Day10.There were 5 days washout period between the two stages.The whole study needs 27 days.This group patient was given treatment from A stage to B stage.
|
The A sequence was that SP2086 was taken at 200mg qd on Days1-Day10; Simvastatin will be administered orally (by mouth) as 40mg on Days 6-Day10.The B sequence was that Simvastatin was taken at 40mg qd dose on Days 6-Day10.
The A sequence was that SP2086 was taken at 200mg qd on Days1-Day10; Simvastatin will be administered orally (by mouth) as 40mg on Days 6-Day10.The B sequence was that Simvastatin was taken at 40mg qd dose on Days 6-Day10.
|
Active Comparator: Simvastatin and SP2086
All subject were randomized into two groups,and the drugs will be administered according to the AB and BA sequences,all subjects must completed the two stages(A and B).The A sequence was that SP2086 was taken at 200mg qd on Days1-Day10; Simvastatin will be administered orally (by mouth) as 40mg on Days 6-Day10.The B sequence was that Simvastatin was taken at 40mg qd dose on Days 6-Day10.There were 5 days washout period between the two stages.The whole study needs 27 days.This group patient was given treatment from B stage to A stage.
|
The A sequence was that SP2086 was taken at 200mg qd on Days1-Day10; Simvastatin will be administered orally (by mouth) as 40mg on Days 6-Day10.The B sequence was that Simvastatin was taken at 40mg qd dose on Days 6-Day10.
The A sequence was that SP2086 was taken at 200mg qd on Days1-Day10; Simvastatin will be administered orally (by mouth) as 40mg on Days 6-Day10.The B sequence was that Simvastatin was taken at 40mg qd dose on Days 6-Day10.
|
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 27
|
Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of multiple doses of SP2086
|
up to Day 27
|
The maximum plasma concentration (Cmax) of SP2086 acid
Time Frame: up to Day 27
|
Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086
|
up to Day 27
|
The maximum plasma concentration (Cmax) of Simvastatin
Time Frame: up to Day 27
|
Cmax (a measure of the body's exposure to Simvastatin) will be compared before and after administration of multiple doses of Simvastatin
|
up to Day 27
|
The area under the plasma concentration-time curve (AUC) of SP2086
Time Frame: up to Day 27
|
AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of multiple doses of SP2086
|
up to Day 27
|
The area under the plasma concentration-time curve (AUC) of SP2086 acid
Time Frame: up to Day 27
|
AUC (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086
|
up to Day 27
|
The area under the plasma concentration-time curve (AUC) of Simvastatin
Time Frame: up to Day 27
|
AUC (a measure of the body's exposure to Simvastatin) will be compared before and after administration of multiple doses of Simvastatin
|
up to Day 27
|
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 27
|
up to Day 27
|
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
July 1, 2013
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
January 3, 2016
First Submitted That Met QC Criteria
June 23, 2016
First Posted (Estimate)
June 28, 2016
Study Record Updates
Last Update Posted (Estimate)
June 28, 2016
Last Update Submitted That Met QC Criteria
June 23, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HR-SP-107
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.
Clinical Trials on Type 2 Diabetes
-
Antonio Di MauroCompletedType-2 DiabetesItaly
-
University of Erlangen-Nürnberg Medical SchoolCompletedType 2-diabetesGermany
-
DiaMedica Therapeutics IncCompletedDiabetes Type 2Netherlands
-
RenJi HospitalUnknownType 2 Diabetes.China
-
Chengdu Brilliant Pharmaceutical Co., Ltd.Not yet recruitingType 2 Diabetes Mellitus
-
Nanjing First Hospital, Nanjing Medical UniversityRecruitingType 2 Diabetes MellitusChina
-
Xiangya Hospital of Central South UniversityRecruitingType 2 Diabetes MellitusChina
-
University of Alabama at BirminghamCompletedType 2 Diabetes MellitusUnited States
-
Imperial College LondonAstraZeneca; Huma; North West London Collaboration of CCGs (NWL CCGs); Imperial...CompletedType 2 Diabetes MellitusUnited Kingdom
-
Universiti Sains MalaysiaCompleted
Clinical Trials on SP2086
-
Jiangsu HengRui Medicine Co., Ltd.Unknown
-
Jiangsu HengRui Medicine Co., Ltd.Unknown
-
Jiangsu HengRui Medicine Co., Ltd.UnknownType 2 DiabetesChina
-
Jiangsu HengRui Medicine Co., Ltd.Completed
-
Jiangsu HengRui Medicine Co., Ltd.CompletedRenal Insufficiency
-
Jiangsu HengRui Medicine Co., Ltd.Unknown
-
Jiangsu HengRui Medicine Co., Ltd.Unknown
-
Jiangsu HengRui Medicine Co., Ltd.Completed
-
Jiangsu HengRui Medicine Co., Ltd.Unknown
-
Jiangsu HengRui Medicine Co., Ltd.Completed