None listed
Conditions
Interventions
multi-dose period, oral administration in the fasting state for 10 days consecutively, 1 tablet, once daily.
Sponsors
Daiichi Sankyo Pharmaceutical (Shanghai) Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1.Healthy male or female; 2.Aged 18 to 45 years; 3.Body weight >= 50 kg, body mass index (BMI) [weight (kg) / height 2 (m2)] is between 19 and 24; 4.Healthy status was confirmed by medical history, comprehensive physical examination and laboratory tests; 5.Subjects signed informed consent form.
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1.Unable or unwilling to sign the informed consent form; 2.Clinically significant abnormalities was found after physical examination, or laboratory tests showed clinically significant abnormal values; 3.Any of the result of serological screening tests, including: HIV antibody, HBV (HBeAg, HBsAg), HCV antibody, TPPA, is positive; 4.Present with a history of cardiovascular, liver, kidney, gastrointestinal, or neurological/mental diseases; 5.With known hypersensitivity to the investigational drug or any ingredient of the investigational drug; 6.Having blood donation within the last 3 months; 7.Systolic blood pressure below 100 mmHg, and/or diastolic blood pressure below 50 mmHg at screening; 8.Pregnant or breast-feeding women, or women of childbearing potential who failed to take effective contraceptive measures; 9.With a history of alcohol dependence or drug abuse, and/or positive result in drug screening or alcohol breath test; 10.The subjects who required elective surgery during the study; 11.Subjects who had participated in drug clinical trial one month before study entry, or had plan to participate in other drug clinical trial during this study; 12.The subjects who received any medication two weeks before study entry (excluding daily dose of not more than 1 g paracetamol); 13.The subjects who smoke > 15 cigarettes/day during the 12 months before screening, and/or positive for tobacco screening test; 14.The ineligibility of subjects to participate in this study was evaluated by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters: The following parameters were determined in single-dose administration period: C max (ng/ml), AUC(0 - t) (micro g.h/L), AUC(0 - infinity) (micro g.h / L), Tmax (h) , T1/2 (h), CL/F (L/h), CLr (L/h), V/F (L), Ke (h-1), the cumulative excretion rate (%), amount of excretion ( mg). The following parameters were determined in multi-dose administration period: Cmax (ng/ml), Cav (ng/ml), Tmax (h), T1/2 (h), CL/F (L/h), V/F (L), Ke (h-1), DF (%), AUCss (0 - t) (micro g.h/L), AUCss (0 - infinity) (micro g.h/L), Ro. Safety parameters: The safety assessment in this study included adverse events, laboratory tests (blood routine tests, urinalysis, blood biochemistry), vital signs, physical examination, 12-lead ECG. | — |
Outcome results
None listed