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Completed

NCT Number: NCT02815787

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SP2086

Drug

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

Drug

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.

Primary outcomes

  1. The maximum plasma concentration (Cmax) of SP2086

    Time frame: 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

  2. The maximum plasma concentration (Cmax) of SP2086 acid

    Time frame: 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

  3. The maximum plasma concentration (Cmax) of Glyburide

    Time frame: 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

  4. The area under the plasma concentration-time curve (AUC) of SP2086

    Time frame: 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

  5. The area under the plasma concentration-time curve (AUC) of SP2086 acid

    Time frame: 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

  6. The area under the plasma concentration-time curve (AUC) of Glyburide

    Time frame: 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

Secondary outcomes

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

    Time frame: up to Day 25

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 28, 2016
Registry last updated
Jun 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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