Study design The study design was a sequential, openlabel, two period trial conducted at the Drug Clinical Research Organization (-)-MK 801 of Yijishan Hospital. Within the morning of day 1, immediately after fasting overnight, a single dose of 15 mg midazolam was administered orally. The volunteers were supplied a light typical meal at 4 h and 10 h immediately after medication intake. At 10 and
min, next 5A : 95B to 70A : 30B and for 6 min. The ow rate was 0. 2 ml min1. Separation by HPLC on a C18 column was followed by mass spectrometric detection. This assay had a lower limit of quantitation of 1. 0 ng ml1, with (-)-MK 801 a calibration curve range from 1. 0 to 500. 0 ng ml1. Intra and interday CV of midazolam and 1 hydroxymidazolam were below 15%. The liquid chromatographCmass spectrometer consisted of an HPLC program and a Finnigan TSQ Quantum Discovery max program equipped with an ESI probe. Lipophilic analytes were extracted from 0. 5 ml plasma, diluted with 10 l of diazepam resolution, with 4 ml ethyl acetate. The samples were centrifuged, evaporated and reconstituted while in the mobile phase. Separation by HPLC on a C18 column was followed by tandem mass
indicates of Cmax : Cmax and AUCmax : AUCmax were 1. 072 and 1. 035, Twelve healthier male Chinese subjects with a mean age of 24 years, a mean weight of 62. 8 kg and a mean height of 172 cm participated within this study. All subjects tolerated danshen and midazolam tablets nicely throughout the study. Full pharmacokinetic data for both sampling periods were readily available for 12 subjects and were included while in the pharmacokinetic analyses. Mean plasma midazolam and 1 hydroxymidazolam concentrationCtime proles ahead of and immediately after 14 days of danshen tablets are presented in Figures 1 and 2. Table 1 summarizes the pharmacokinetic parameters of midazolam and 1 hydroxymidazolam ahead of and immediately after 14 days of treatment with danshen tablets. For midazolam, values of Cmax were 113. 98 and 72. 50 ng ml1, respectively. Ninety percent CIs of Cmax NSCLC and AUC of midazolam and 1 hydroxymidazolam were under the lower statistical limit set but 90% CIs of t1/2 were within the variety of statistical
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