The PK/PD Study of Single Dose of SHR3824 in Healthy Volunteers

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

SHR3824 is a novel inhibitor of renal sodium-glucose cotransporter 2, allows an insulin-independent approach to improve type 2 diabetes hyperglycemia. In this single-dose study the investigators evaluated the safety, tolerablity and PK/PD profiles of SHR3824 in healthy subjects.

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

Details

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

Criteria

Inclusion criteria:

• Chinese male and female subjects aged 18 to 45 years.

• BMI:18 -25 kg/m2 .

• Healthy according to medical history, physical examination findings, 12-lead ECG findings, and clinical laboratory evaluations.

Exclusion criteria:

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

• History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose.

• Pregnancy or breastfeeding .

• Significant acute or chronic medical illness, including renal impairment, or recent surgery.

• Donation of blood or plasma within the 4 weeks prior to the start of the study or acception of blood transfusion within 8 weeks.