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Mechanics / Mech Engineering
Medical: Health Care
Sample translations submitted: 1
English to Chinese: medical
Source text - English 5.2.2 A Double-Blind, Randomized, Placebo-Controlled, Multi-Panel, Multiple Oral Dose Study, to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of XXX in Healthy Male and Postmenopausal Female Subjects (Protocol 002)
This was a randomized, double-blind, placebo-controlled, sequential group, multiple oral dose study in 36 healthy young men and 40 postmenopausal women to assess safety, tolerability, pharmacokinetics, and pharmacodynamic profile of XXX during multiple oral dosing. Four panels (Panels A, B, C, and D) of 9 male subjects (6 active, 3 placebo) were administered doses of XXX or placebo once daily for 20 days. Four panels (Panels E, F, G and H) of 10 postmenopausal female subjects (8 active, 2 placebo) were administered doses of XXX or placebo once daily for 25 days, beginning after completion of the first panel of healthy young men. Subjects participated in only one panel and received only one dose level. Panels A, B, C, and D were administered 2.5, 5, 10, and 25 mg XXX (n=6) or placebo (n=3), respectively. Panels E, F, G and H were administered 0.5, 2.5, and 10 mg XXX (n=8) or placebo (n=2), respectively. Blood and urine samples were obtained at selected time points pre and post dose for XXX concentrations and for measurement of serum CTx, urinary NTx/Cre, C-terminal crosslinked telopeptides of type II collagen (CTx-II), serum cartilage oligomeric matrix protein (COMP).
Mean concentrations of XXX in plasma following administration of once daily multiple oral doses of 2.5, 5, 10, and 25 mg in the male panels and 0.5, 2.5, and 10 mg in the female panels are shown in Table 5-5. The preliminary pharmacokinetic results from the once daily multiple dose study indicate that by the last dose (Day 20 for men and Day 25 for women), the concentration-time profile appears to be approaching steadystate. In women, the AUC0-24 hr, Cmax and C24 hr accumulated ~4- to 5-fold, with 25 days of once daily administration of 0.5 to 10 mg of XXX. Day 20 AUC0-24 hr, Cmax, and C24 hr increase approximately dose-proportionally over the dose range of 2.5 to 10 mg in men, and 0.5 to 10 mg in women. In men, Day 20 AUC0-24 hr, Cmax, and C24 hr increase less than dose proportional when doses increase from 10 to 25 mg. For the 2.5-mg dose, Day 25 AUC0-24 hr, Cmax, and C24 hr in postmenopausal women are 63, 64, and 50% higher, respectively, than Day 20 in men
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