The Drug-drug Interaction of SP2086 and Simvastatin

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to investigate the potential interaction between SP2086 and Simvastatin after the multiple oral doses treatment in healthy adult volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Simvastatin

Criteria

Inclusion Criteria:

• Healthy volunteers with a body mass index(BMI) between 19 and 24 Kg/m2

• Had signed the informed consent himself or herself voluntarily.

Exclusion Criteria:

• Have the abnormal lab or other examination results and the change have clinical significance.

• History of or current clinically significant medical illness as determined by the Investigator.

• Have a family history of thyroid cancer, submandibular gland cancer or long QT syndrome

• 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.