Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
An open-label, balanced, randomized, two-treatment, two-sequence, two-period, crossover, single dose oral relative bioavailability study of a novel PanCytoVir™ oral suspension (100 mg/mL) versus probenecid 500 mg tablets in normal healthy, adult, human subjects under fasting conditions.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PanCytoVir™ 1000 mg (100 mg/mL) | Experimental | PanCytoVir™ oral suspension (100 mg/mL) |
|
| Probenecid 1000 mg (2x500 mg tablets) | Experimental | Probenecid 500 mg tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PanCytoVir™ 100 mg/mL oral suspension | Drug | Single oral dose of 1000 mg (100 mg/mL) under fasted conditions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bioavailability comparison using Cmax | 7 days | |
| Bioavailability comparison using AUC | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 (%). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David E Martin, PharmD | TrippBio, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vayam Research Solutions Limited | Gujrāt | India |
Plans are currently under development
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013535 | Suspensions |
| D011339 | Probenecid |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Probenecid 500 mg | Drug | Single oral dose of 1000 mg under fasted conditions |
|
| 7 days |
| D013449 |
| Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |