Clinical trial NCT02815657: The Drug-drug Interaction of SP2086 and Valsartan
Official title: A Single Randomized, Open,Cross-over, Phase I Study to Access the Drug-drug Interaction of SP2086 and Valsartan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Keywords: SP2086
Valsartan
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 Valsartan after multiple oral doses treatment in healthy adult volunteers.

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 Valsartan in healthy adult volunteers. 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 Valsartan was taken at 160mg qd on Days1-Day12; SP2086 will be administered orally (by mouth) as 200mg on Days 8-Day12.The B sequence was that SP2086 was taken at 200mg qd dose on Days 8-Day12.There were 6 days washout period between the two stages. The whole study needs 31 days.

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.
* 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.

Primary outcomes:
measure: The maximum plasma concentration (Cmax) of SP2086
timeFrame: up to Day 31
measure: The maximum plasma concentration (Cmax) of SP2086 acid
timeFrame: up to Day 31
measure: The maximum plasma concentration (Cmax) of valsartan
timeFrame: up to Day 31
measure: The area under the plasma concentration-time curve (AUC) of SP2086
timeFrame: up to Day 31
measure: The area under the plasma concentration-time curve (AUC) of SP2086 acid
timeFrame: up to Day 31
measure: The area under the plasma concentration-time curve (AUC) of valsartan
timeFrame: up to Day 31
Secondary outcomes:
measure: The number of volunteers with adverse events as a measure of safety and tolerability
timeFrame: up to Day 31
Other outcomes:
Locations:
city: Chengdu
country: China
facility: People's Liberation Army General Hospital of Chengdu Military Region
Study officials:
affiliation: People's Liberation Army General Hospital of Chengdu Military Region
name: XiaoLan Yong, P.H.D
role: PRINCIPAL_INVESTIGATOR
References: