TriangleNCT00652626 · OUTCOME
Time to Maximum Plasma Concentration of Azacitidine (Tmax)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- hours
- Interval / dispersion
- Full Range
- 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 time to first maximum observed plasma concentration of azacitidine after a single dose on Day 1.
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 | 0.25 | Not reported | 0.25 | 1.00 | Not reported |
| Azacitidine 50 mg/m^2 | 0.25 | Not reported | 0.25 | 0.78 | Not reported |
| Azacitidine 75 mg/m^2 | 0.25 | Not reported | 0.25 | 0.50 | Not reported |
| Azacitidine 100 mg/m^2 | 0.27 | Not reported | 0.25 | 0.75 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.25
- upper Limit
- 1.00
- value
- 0.25
- group Id
- OG001
- lower Limit
- 0.25
- upper Limit
- 0.78
- value
- 0.25
- group Id
- OG002
- lower Limit
- 0.25
- upper Limit
- 0.50
- value
- 0.25
- group Id
- OG003
- lower Limit
- 0.25
- upper Limit
- 0.75
- value
- 0.27
- 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 time to first maximum observed plasma concentration of azacitidine after a single dose on Day 1.
- dispersion Type
- Full Range
- 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
- MEDIAN
- 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
- Time to Maximum Plasma Concentration of Azacitidine (Tmax)
- type
- PRIMARY
- unit Of Measure
- hours
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice