The Drug -Drug Interaction of SP2086 and Glyburide

A Single Randomized, Open, Cross-over, Phase Ie Study to Access the Drug-drug Interaction of SP2086 and Glyburide

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: SP2086; Drug: Glyburide

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital of Shandong University

Participation Criteria

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SP2086 and 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.	Drug: SP2086; In the A sequence 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.In 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.; Drug: Glyburide; In the A sequence 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.In 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.
Active Comparator: Glyburide and 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.	Drug: SP2086; In the A sequence 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.In 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.; Drug: Glyburide; In the A sequence 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.In 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The maximum plasma concentration (Cmax) of SP2086	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 25
The maximum plasma concentration (Cmax) of SP2086 acid	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 25
The maximum plasma concentration (Cmax) of Glyburide	Cmax (a measure of the body's exposure to Glyburide) will be compared before and after administration of multiple doses of Glyburide	up to Day 25
The area under the plasma concentration-time curve (AUC) of SP2086	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 25
The area under the plasma concentration-time curve (AUC) of SP2086 acid	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 25
The area under the plasma concentration-time curve (AUC) of Glyburide	AUC (a measure of the body's exposure to Glyburide) will be compared before and after administration of multiple doses of Glyburide	up to Day 25

Secondary Outcome Measures

Outcome Measure	Time Frame
The number of volunteers with adverse events as a measure of safety and tolerability	up to Day 25

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Investigators: Principal Investigator: RuiChen Guo, M.D, Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 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: drug-drug interaction; Glyburide; SP2086
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Glyburide
• Other Study ID Numbers: QLHCPI-179