Overview

The Drug-drug Interaction of SP2086 and Valsartan

Status:
Completed
Trial end date:
2014-01-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of the study is to investigate the potential interaction between SP2086 and Valsartan after 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:
Valsartan
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.

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.