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CompletedNCT02815787Updated Jun 28, 2016

The Drug -Drug Interaction of SP2086 and Glyburide

A Phase 1 interventional study of SP2086 and Glyburide in Type 2 Diabetes, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-28.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Type 2 Diabetes

Keywords

  • SP2086
  • Glyburide
  • drug-drug interaction
03

In context

Diabetes Mellitus, Type 2

9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's enrollment of 16 is below the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 570 studies on the registry; 85 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 1 (10%) have results posted.

Browse Jiangsu HengRui Medicine Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • 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 · Drug: Glyburide

  • 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 · Drug: Glyburide

Interventions

  • DrugSP2086

    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.

  • DrugGlyburide

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: up to Day 25

  2. 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

    Time frame: up to Day 25

  3. 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

    Time frame: up to Day 25

  4. 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

    Time frame: up to Day 25

  5. 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

    Time frame: up to Day 25

  6. 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

    Time frame: up to Day 25

Secondary outcomes

  1. The number of volunteers with adverse events as a measure of safety and tolerability

    Time frame: up to Day 25

07

Study locations

1 site
  • Qilu Hospital of Shandong University
    Jinan, Shandong 250012, China
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2014, a primary completion of Jul 2014 and a completion of Jul 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 3, 2016
First posted
Jun 28, 2016
Start
Mar 2014
Primary completionActual
Jul 2014
CompletionActual
Jul 2014
Last update
Jun 28, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02815787
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Jun 28, 2016
Start date
Mar 2014
Primary completion
Jul 2014
Completion
Jul 2014
Last update
Jun 28, 2016

Study contacts

RuiChen Guo, M.D
principal investigator · Qilu Hospital of Shandong University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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