The Metabolite Identification and Material Balance Study of SP2086

Hengrui Medicine

Status and phase

Completed

Phase 1

Conditions

Type 2 Diabetes

Treatments

Drug: SP2086

Study type

Interventional

Funder types

Industry

Identifiers

HR-SP2086-109

Details and patient eligibility

About

The purpose of the study is to investigate the Metabolite identification and material balance of SP2086 in healthy adult volunteers.

Full description

All subjects were given SP2086 100mg only one time, and blood sample should be collected before and 96 hours after medicine taken.

Enrollment

8 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy volunteers with a body mass index(BMI) between 19 and 25 Kg/m2,and weight ≥50kg.
Lab and other examination results were normal or mildly abnormal without clinical significance, clinical doctors had considered eligible.
Had signed the informed consent himself or herself voluntarily.

Exclusion criteria

Has a history of severe system disease, or family history (including the cardiovascular system, digestive system, urinary system, etc.).
Has a history of allergy or intolerance to SP2086 OR other DPP-IV.
The subjects participated 3 times or more than 3 times drug clinical subjects in nearly a year;participate any drug clinical trial prior to the test 3 months, or had blood donor, or plan to blood donors three months before the test;or had a transfusion in 4 weeks.
Did not take effective contraceptive measures or planning of the subjects in half a year.
Researchers considered the patient adherence is poor, or has any unfavorable factors that not suit to participate the test.