Pharmacokinetic study of olmesartan medoxomil/amlodipine 20/5 mg tablet in Chinese healthy adult volunteers
- Conditions
- -
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 10
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetic parameters:<br>The following parameters were determined in single-dose administration period: <br>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). <br>The following parameters were determined in multi-dose administration period: <br>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.<br>Safety parameters:<br>The safety assessment in this study included adverse events, laboratory tests (blood routine tests, urinalysis, blood biochemistry), vital signs, physical examination, 12-lead ECG.
- Secondary Outcome Measures
Name Time Method