Clinical trial NCT02815787: The Drug -Drug Interaction of SP2086 and Glyburide
Official title: A Single Randomized, Open, Cross-over, Phase Ie Study to Access the Drug-drug Interaction of SP2086 and Glyburide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Keywords: SP2086
Glyburide
drug-drug interaction
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-06-28
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the potential interaction between SP2086 and Glyburide after the singe and multiple oral doses treatment in healthy adult volunteers respectively.

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 Glyburide 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 Glyburide was taken at 5mg qd dose on Days1,4,5,6,7 and 8; SP2086 will be administered orally (by mouth) as 200mg on Days 8.The B sequence was that SP2086 was taken at 200mg qd dose on Days1,4,5,6,7 and 8; Glyburide will be administered orally (by mouth) as 200mg on Days 8.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers with a body mass index(BMI) between 19 and 24 Kg/m2
* Had signed the informed consent himself or herself.

Exclusion Criteria:

* Have the abnormal lab or other examination results and the change have clinical significance.
* 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.

Primary outcomes:
measure: The maximum plasma concentration (Cmax) of SP2086
timeFrame: up to Day 25
measure: The maximum plasma concentration (Cmax) of SP2086 acid
timeFrame: up to Day 25
measure: The maximum plasma concentration (Cmax) of Glyburide
timeFrame: up to Day 25
measure: The area under the plasma concentration-time curve (AUC) of SP2086
timeFrame: up to Day 25
measure: The area under the plasma concentration-time curve (AUC) of SP2086 acid
timeFrame: up to Day 25
measure: The area under the plasma concentration-time curve (AUC) of Glyburide
timeFrame: up to Day 25
Secondary outcomes:
measure: The number of volunteers with adverse events as a measure of safety and tolerability
timeFrame: up to Day 25
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: RuiChen Guo, M.D
role: PRINCIPAL_INVESTIGATOR
References: