The Drug -Drug Interaction of SP2086 and Glyburide
- Registration Number
- NCT02815787
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- Healthy volunteers with a body mass index(BMI) between 19 and 24 Kg/m2
- Had signed the informed consent himself or herself.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description SP2086 and Glyburide SP2086 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.The trial period were 25 days. In this group,the subjects was given the drugs from A sequence to the B sequence. Glyburide and SP2086 Glyburide 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.The trial period were 25 days.In this group,the subjects was given the drugs from B sequence to the A sequence. SP2086 and Glyburide Glyburide 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.The trial period were 25 days. In this group,the subjects was given the drugs from A sequence to the B sequence. Glyburide and SP2086 SP2086 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.The trial period were 25 days.In this group,the subjects was given the drugs from B sequence to the A sequence.
- Primary Outcome Measures
Name Time Method The maximum plasma concentration (Cmax) of SP2086 up to Day 25 Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of multiple doses of SP2086
The maximum plasma concentration (Cmax) of SP2086 acid up to Day 25 Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086
The maximum plasma concentration (Cmax) of Glyburide up to Day 25 Cmax (a measure of the body's exposure to Glyburide) will be compared before and after administration of multiple doses of Glyburide
The area under the plasma concentration-time curve (AUC) of SP2086 acid up to Day 25 AUC (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086
The area under the plasma concentration-time curve (AUC) of Glyburide up to Day 25 AUC (a measure of the body's exposure to Glyburide) will be compared before and after administration of multiple doses of Glyburide
The area under the plasma concentration-time curve (AUC) of SP2086 up to Day 25 AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of multiple doses of SP2086
- Secondary Outcome Measures
Name Time Method The number of volunteers with adverse events as a measure of safety and tolerability up to Day 25
Trial Locations
- Locations (1)
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China