Evaluate the Pharmacokinetics of Digoxin When Coadministered With PEX168 in Healthy Adult Subjects

• Status: Completed
• Trial end date: 2016-01-18
• Target enrollment: 0
• Participant gender: Male

Summary

To assess the effect of PEX168 doses on the pharmacokinetics of digoxin in healthy subjects.To provide a scientific basis for clinical drug combination of PEX168.

To assess the safety of single doses of digoxin administered with and without PEX168

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

Details

• Lead Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
• Treatments: Digoxin

Criteria

Inclusion Criteria:

1. Healthy male aged 18 to 45 years (including both ends) at the time of signing the informed consent.

2. Weighing not less than 50kg，Body Mass Index (BMI)of 18 to 25kg/m2.

3. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), total bilirubin (Tbil) are within the normal range during screening;

4. Estimated creatinine clearance (Clcr) ≥90ml / min calculated by the Cockcroft-Gault (CG) formula ;

5. Capable of giving written informed consent, which included compliance with the requirements and restrictions listed in the consent form.

Exclusion Criteria:

1. The hepatitis B surface antigen, hepatitis C antibody, HIV antibody test positive;

2. Having history of syncope, palpitations, bradycardia, tachycardia and other anomalies(such as the extent of any way block, left bundle branch block, right bundle branch block), or via a comprehensive physical examination (vital signs, physical examination), routine laboratory tests (blood count, blood biochemistry, urine, etc.), 12-lead ECG, abdominal B ultrasound (liver, gallbladder, pancreas, spleen, kidney), and other abnormalities and clinical significance persons before screening;

3. Having Alcohol and drug abuse within first 6 months before screening;

4. Smoked within 3 months before screening;

5. In screening period, blood pressure greater than 140 / 90mmHg, retest after diagnosis or pulse rate is higher than 100bpm person;

6. In screening period, ECG QTc> 450ms,diagnosed after retest;

7. Having a history of drug or allergic reactions or allergic constitution have hypersensitivity to any of the following:

1) digoxin and / or any of its ingredients or other similar drugs . 2) PEX168

8. Before screening, having a history of cardiovascular disease (coronary heart disease, high blood pressure, high cholesterol, etc.) or a history of pulmonary disease (chronic bronchitis, emphysema, asthma, pneumonia, etc.);

9. In screening period , fasting triglycerides test result was greater than the upper limit of normal range;

10. Currently there is a history of liver disease or liver disease or a known hepatobiliary abnormalities (except asymptomatic gallstones);

11. Participate in blood donation and donation amount ≥400ml within three months before screening, or who participate in blood donation or blood transfusion within a month;

12. In screening period, having thyroid dysfunction or a history;

13. The history of gastrointestinal surgery (such as stomach cutting surgery, gastric bypass surgery) before screening;

14. The history of pancreatitis;

15. History of cholecystitis gallbladder disease or other disease history;

16. The history of inflammatory bowel disease or a history of irritable bowel syndrome;

17. The history of Type 2 multiple endocrine neoplasia;

18. The history of medullary thyroid cancer;

19. The family has type 2 multiple endocrine fibromatosis or a history of medullary thyroid cancer;

20. 3 months before screening, participating in any drug or medical device trials are (including placebo);

21. Using any of the tested drugs may affect prescription drugs , non-prescription drugs, herbal (especially ginseng, oral hypoglycemic agents) or multivitamin supplements persons;

22. Drinking medication or caffeine-containing xanthine food and beverage (listed in annex 3), strenuous exercise, or other effects of drug absorption, distribution, metabolism, excretion and other factors 2 days before screening.

23. Received GLP-1 analogs (e.g. exenatide) treatment;

24. Reluctant to take an effective method of contraception during the test, fertility planner within six months after his or her spouse during the test or the last dose (38 days);

25. Researchers believe any situation that might lead to any subject cannot complete the study or to the subject of this study bring significant risk.