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Urine samples for the PK profile after the multiple dose phase were taken on day 12 at 0 4, 4 8, 8 12, 12 24, 24 36, 36 48 h after the last dose of the multiple dose phase.
In the multiple dose phase, they were also conducted on days 5 and 10, before drug administration.
Detailed analysis of the finger-stick samples gathered during the multiple dose phase showed a strictly proportional response to dose.
Spirometry (forced expiratory volume in 1 s, FEV1) was measured before each dose of MSF during the multiple dose phase.
In the multiple dose phase AChE was assayed at the time of drug administration on days 1, 3, 5, 8, 10 and 12 (drug days).
A comprehensive motor examination was also conducted each morning from the first day of the single dose phase until 2 days after the final dose of the multiple dose phase.
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Subjects who dropped out for other than AEs were replaced and the replacements underwent both the single and multiple dose phases.
In a single-and multiple-dose phase I clinical trial in healthy Korean subjects.
This randomized, double-blind, placebo-controlled, multiple-dose, phase 1 study was conducted at four study centers in Japan.
GSK 2828232 has recently entered multiple-dose Phase I studies for examining its safety and food and drug interactions in healthy volunteers.
Safety and pharmacokinetic data from single- and multiple-dose phase I trials of lapatinib in healthy volunteers have recently been published (Bence et al. 2005).
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