TriangleNCT00652626 · OUTCOME
Apparent Volume of Distribution of Azacitidine (Vz/F)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- liters
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose
What was measured
The apparent volume of distribution of azacitidine after a single dose on Day 1, calculated according to the equation: Vz/F = Apparent total clearance (CL/F) / terminal phase rate constant (λz)
Analysis population: Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.
Groups in this outcome
Azacitidine 25 mg/m^2
Participants with normal renal function (defined as creatinine clearance \> 80 mL/min/1.73m\^2) received a single subcutaneous dose of azacitidine 25 mg/m\^2 on Day 1.
Azacitidine 50 mg/m^2
Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m\^2 on Day 1.
Azacitidine 75 mg/m^2
Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
Azacitidine 100 mg/m^2
Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m\^2 on Day 1.
| Group | Source count |
|---|---|
| Azacitidine 25 mg/m^2 | 5 |
| Azacitidine 50 mg/m^2 | 5 |
| Azacitidine 75 mg/m^2 | 6 |
| Azacitidine 100 mg/m^2 | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Azacitidine 25 mg/m^2 | 208.69 | 45.57 | Not reported | Not reported | Not reported |
| Azacitidine 50 mg/m^2 | 96.74 | 36.75 | Not reported | Not reported | Not reported |
| Azacitidine 75 mg/m^2 | 259.44 | 121.71 | Not reported | Not reported | Not reported |
| Azacitidine 100 mg/m^2 | 456.69 | 99.41 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 45.57
- value
- 208.69
- group Id
- OG001
- spread
- 36.75
- value
- 96.74
- group Id
- OG002
- spread
- 121.71
- value
- 259.44
- group Id
- OG003
- spread
- 99.41
- value
- 456.69
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 5
- units
- Participants
- description
- The apparent volume of distribution of azacitidine after a single dose on Day 1, calculated according to the equation: Vz/F = Apparent total clearance (CL/F) / terminal phase rate constant (λz)
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants with normal renal function (defined as creatinine clearance \> 80 mL/min/1.73m\^2) received a single subcutaneous dose of azacitidine 25 mg/m\^2 on Day 1.
- id
- OG000
- title
- Azacitidine 25 mg/m^2
- description
- Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m\^2 on Day 1.
- id
- OG001
- title
- Azacitidine 50 mg/m^2
- description
- Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
- id
- OG002
- title
- Azacitidine 75 mg/m^2
- description
- Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m\^2 on Day 1.
- id
- OG003
- title
- Azacitidine 100 mg/m^2
- param Type
- GEOMETRIC_MEAN
- population Description
- Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.
- reporting Status
- POSTED
- time Frame
- Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose
- title
- Apparent Volume of Distribution of Azacitidine (Vz/F)
- type
- PRIMARY
- unit Of Measure
- liters
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice