Open-label, single-dose and multiple-dose clinical trial
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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:
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.
18age old over
45age old under
Both
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investigational material(s)
Generic name etc : Olmesartan Medoxomil/Amlodipine
INN of investigational material : olmesartan medoxomil/amlodipine
Therapeutic category code : 214 Antihypertensives
Dosage and Administration for Investigational material : Olmesartan medoxomil/amlodipine tablets, strength: 20/5 mg.Drug administration: single-dose period, oral administration of single dose in the fasting state; multi-dose period, oral administration in the fasting state for 10 days consecutively, 1 tablet, once daily.
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.
