This is an open-label, balanced, randomized, two-period, crossover, single dose study to compare the relative bioavailability in normal healthy, adult, human subjects under Fed and Fasting conditions. Subjects will receive a single oral dose of probenecid oral suspension (100 mg/mL) under fed and fasted conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
PanCytoVir™ 100 mg/mL oral suspension
Vayam Research Solutions Limited
Gujarat, India, India
To assess food effect on PanCytoVir™ in healthy, adult, human subjects as assessed by Cmax
The drug concentration in plasma assessed by Cmax
Time frame: 7 days
To assess food effect on PanCytoVir™ in healthy, adult, human subjects as assessed by AUC
The drug concentration in plasma assessed by AUC
Time frame: 7 days
the Incidence rates of AEs, TEAEs and Serious Adverse Events (SAEs)
Numbers and incidence rates of AEs, TEAEs and Serious Adverse Events (SAEs) will be tabulated using available version of Medical Dictionary for Regulatory Activities (MedDRA) preferred term (PT), system organ class (SOC), severity and relationship. A patient having the same AE will be counted only once in calculating frequency while patient having same AE with different start date then both will be considered for calculating frequency. If AE is with same start date but different criteria (severity, relationship to study medication and outcome), worst case/latest case (whichever applicable) will be considered. Incidence of AEs will be summarized with count (%).
Time frame: 7 days
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