Healthy Subjects Clinical Trial
Official title:
An Open-label, Prospective Study of Safety, Tolerability, Pharmacokinetics and Food Effects of PBTZ169, 80 mg Capsules, When Used in Ascending Doses in Healthy Volunteers
Open-label prospective non-comparative ascending dose randomized cohort study of single and multiple oral administration of PBTZ169 (capsules 80 mg) in healthy volunteers
Open-label prospective non-comparativerandomized cohort study of safety, tolerability,
pharmacokinetics and the effect of food of PBTZ169 in adult healthy volunteers after single
and multiple oral administration. Study was conducted in one study center in the Russian
Federation. The study included two stages:
Stage 1 - single or double oral administration with dose escalation (fasted/after meal) in 5
cohorts 10 healthy volunteers each plus 5 back-up volunteers;
Stage 2 - multiple oral administration once a day after meal for 14 days in 1 cohort of 10
healthy volunteers.
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