An Evaluation of the Effect of Food on the PK of a Novel PanCytoVir™ Suspension (100mg/ml), in He… (NCT06025318) | Clinical Trial Compass
CompletedPhase 1
An Evaluation of the Effect of Food on the PK of a Novel PanCytoVirâ„¢ Suspension (100mg/ml), in Healthy, Adult Volunteers
India14 participantsStarted 2024-09-01
Plain-language summary
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.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. Normal healthy adult human subjects.
✓. Subjects who are willing to participate and give informed consent
✓. Subjects who are ≥ 18 years of age to ≤ 45 years of age and have a Body Mass Index between ≥18.5 to ≤ 30.0 kg/m2 extremes included, with weight of at least 50 kg.
✓. Subjects with normal findings as determined by baseline history, physical examination and vital sign examination (blood pressure, pulse rate, respiration rate and body temperature).
✓. Subjects with clinically acceptable findings as determined by haemogram, biochemistry, urine analysis, 12 lead ECG and chest X-ray.
✓. Willingness to follow the protocol requirements especially abstaining from xanthine containing food or beverages (chocolates, tea, coffee or cola drinks) or grapefruit juice, any alcoholic products, the use of cigarettes and the use of tobacco products for 72.00 hours prior to dosing until after the last blood sample collection in each study period and adherence to food, fluid and posture restrictions.
✓. No history of significant alcoholism.
✓. Subject who have an estimated glomerular filtration rate (eGFR) value is \>60ml/min.
Exclusion criteria
✕. History of allergic responses or hypersensitivity to Probenecid or other related drugs, or any of its ingredients.
✕. Requiring medication for any ailment having enzyme-modifying activity in the previous 21 days, prior to dosing day.
What they're measuring
1
To assess food effect on PanCytoVirâ„¢ in healthy, adult, human subjects as assessed by Cmax
Timeframe: 7 days
2
To assess food effect on PanCytoVirâ„¢ in healthy, adult, human subjects as assessed by AUC
✕. Subjects who have taken prescription medications or over-the-counter products (including vitamins and minerals) within 14 days prior to administration of study drug
✕. Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
✕. History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, haematological, gastrointestinal, endocrine, immunological or psychiatric diseases.
✕. Participation in a clinical drug study or bioequivalence study 90 days prior to period I dosing of the present study.
✕. History of malignancy or other serious diseases.
✕. Blood donation 90 days prior to period I dosing of the present study.