价格千字70元（中文）
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This was a Phase 1, randomized, double-blind, placebo-controlled, 2-way crossover study to determine the effect of 200 mg oral TR-701 FA once daily on SBP response to tyramine in healthy adult male and female volunteers. The study consisted of a single 100-mg tyramine challenge, followed by 2 treatment periods during which subjects received either TR-701 FA 200 mg or placebo daily with ascending doses of tyramine.
On the morning prior to first study drug administration in Treatment Period 1, subjects were to receive an initial 100 mg tyramine challenge under fasted conditions, and subjects with an increase in SBP of ≥30 mmHg within 2 hours were not eligible for randomization.
Eligible subjects were to be randomized to 1 of 2 treatment sequences (N=15 per sequence, TR-701 FA then placebo or placebo then TR-701 FA). Subjects received oral 200 mg TR-701 FA or placebo daily with water beginning on Day 1 of each treatment period. Subjects were to fast for at least 7 hours before until at least 4 hours after study drug administration. Blood samples for TR-701 and TR-700 trough plasma concentration measurements were to be collected each morning within 15 minutes prior to study drug administration.
Beginning on Day 3 of each treatment period, tyramine was to be administered once a day with water 2 hours after study drug administration. Administration of tyramine was to begin with 25 mg on Day 3 and to increase by 50 mg each day up to a possible maximum dose of 575 mg on Day 14. Extensive blood pressure monitoring occurred at 20, 15, and 10 minutes (±2 minutes) prior to tyramine administration and every 5 minutes (±2 minutes) for at least 2 hours after tyramine administration.
Study drug and tyramine administrations were to continue each morning until TYR30 (increase in SBP of ≥30 mmHg from pre-tyramine dose on Day 3 sustained for 3 measurements at least 5 minutes apart) was reached or through Day 14, whichever occurred first. A minimum washout period of 48 hours between Treatment Periods 1 and 2 was required.
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