diabetes
Conditions
Interventions
Group 20mg:Subjects will receive 8 doses of 20 mg MP-513.
Group 40mg:Subjects will receive 1 dose of 40 mg MP-513.
Group 80mg:Subjects will receive 1 dose of 80 mg MP-513.
Sponsors
Beijing Shijitan Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) A signed and dated informed consent form (ICF) has been obtained from the subject, in accordance with International Conference on Harmonisation guidelines (ICH)on Good Clinical Practice (GCP), before any screening or study related procedures take place; (2) Aged =18 years at the time of signing the ICF; (3) Maleor female of Chinese population; (4) Body mass index (BMI) is =19.0 and =28.0 kg/m2 and whose body weight is =50 kg at the screening visit; (5) Judged by theinvestigatorto be in good health based on medical history, physical examination, and laboratory tests; (6) Judged by the investigator to be able to complete the study.
Exclusion criteria
Exclusion criteria: (1) The subject has ever hadanyabnormality of heart, hepatic, renal, gastrointestinal system, respiratory system, nervous system, hematopoietic function or endocrine function or the other abnormalities are judged by investigation as clinical significance; (2) The subject has a history of significant allergies (including foodor drug allergies); (3) The subject has a history of drug abuse or tests positive for drugs of abuse at the screening visit; (4) The subject has a history of blood donation or hemorrhage of ?400mL within 3 months prior to the screening visit; (5) The subject has a history of the gastrointestinal system surgery (except appendectomy and hernia) that may affect gastrointestinal absorption of drugs; (6) The subject has any clinically significant electrocardiogram (ECG) abnormalities at the screening visit and Day-1; (7) The subject has positive results for Hepatitis B surface (HBs) antigen, Hepatitis C virus (HCV) antibody, Human immunodeficiency virus (HIV) 1 and 2 antibodies or serological test for syphilisor Hepatitis B virus nucleic acid detection with >2.5 *10^2 copies/mlat the screening visit. (8) The subject drinks on average more than 28 units of alcohol per week (One unit of alcohol equals approximately 250 mL of beer, 125 mL of wine or 20 mL of spirits.) or cannot abstain from screening visit to the conclusion of the follow-up visit; (9) The subject smokes on average more than 5 cigarettes per day or cannot abstain from screening visit to the conclusion of the follow-up visit; (10) The male subject and female subject of childbearing potential, who do not agree to prevent conception during the study. Females of childbearing potential (including those less than 2 years postmenopausal) must agree to maintain reliable birth control throughout the study. Reliable contraception is defined as an intrauterine device, or doublebarrier methods (diaphragm plus condom); (11) Female subject who is pregnant, lactating or planning to become pregnant during the study; (12) The subject has participated in any other clinical study involving blood draws or administration of an unlicensed medicinal product within 3 months prior to the screening visit; (13) The subject has used any other drugs (including herbal medicine) within 14 days prior to the first dose of the investigational product; (14) The subject has consumed products containing grapefruit within 7 days prior to the first dose of the investigational product; (15) The subject has consumed products containing St. Johns Wart within 14 days prior to the first dose of the investigational product; (16) The subject is unsuited to participate in the study for any other reason in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood Pressure;Pulse;Temperature;ECG;Blood Routine Examination;Routine Urine Examination;Blood Biochemical; | — |
Countries
China
Contacts
Public ContactXinghe Wang
Beijing Shijitan Hospital Capital Medical University
Outcome results
None listed