The Drug -Drug Interaction of SP2086 and Glyburide

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02815787
• Other study ID #: QLHCPI-179
• Status: Completed
• Phase: Phase 1
• First received: January 3, 2016
• Last updated: June 23, 2016
• Start date: March 2014
• Est. completion date: July 2014

Study information

• Verified date: June 2016
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	The number of volunteers with adverse events as a measure of safety and tolerability		up to Day 25	Yes