TriangleNCT00925782 · OUTCOME
Area Under the Curve (0-t)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- min*ng/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Day -3 and Day -2
What was measured
AUC (0-t) was one of the pharmacokinetic endpoints to confirm pharmacokinetic similarity between Melphalan HCl for Injection (Propylene Glycol-Free) and Alkeran for Injection in patients with multiple myeloma. Pharmacokinetic similarity was defined as a difference of 20% or less in the 90% confidence intervals (CIs) for the ratios of the pharmacokinetic parameters (calculated using log-transformed data) for the two formulations. The AUC results provided is the summary of Melphalan PK following Melphalan-Alkeran injection in Sequence 1 and Alkeran-melphalan injection in Sequence 2.
Analysis population: The pharmacokinetic-evaluable population was defined as all patients who completed dosing and adequate pharmacokinetic blood draws for the calculation of AUC and Cmax for both Melphalan HCl for Injection and Alkeran for Injection. The results are presented by each drug group that combines data from both sequence.
Groups in this outcome
Melphalan
Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients. This group includes all patients with Melphalan dose administration regardless of cross over sequence
Alkeran
Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients. This group includes all patients with Alkeran dose administration regardless of cross over sequence
| Group | Source count |
|---|---|
| Melphalan | 24 |
| Alkeran | 24 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Melphalan | 376577 | 93401 | 105 | 118 | Not reported |
| Alkeran | 341183 | 91349 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 105
- spread
- 93401
- upper Limit
- 118
- value
- 376577
- group Id
- OG001
- spread
- 91349
- value
- 341183
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 24
- units
- Participants
- description
- AUC (0-t) was one of the pharmacokinetic endpoints to confirm pharmacokinetic similarity between Melphalan HCl for Injection (Propylene Glycol-Free) and Alkeran for Injection in patients with multiple myeloma. Pharmacokinetic similarity was defined as a difference of 20% or less in the 90% confidence intervals (CIs) for the ratios of the pharmacokinetic parameters (calculated using log-transformed data) for the two formulations. The AUC results provided is the summary of Melphalan PK following Melphalan-Alkeran injection in Sequence 1 and Alkeran-melphalan injection in Sequence 2.
- dispersion Type
- Standard Deviation
- groups
- description
- Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients. This group includes all patients with Melphalan dose administration regardless of cross over sequence
- id
- OG000
- title
- Melphalan
- description
- Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients. This group includes all patients with Alkeran dose administration regardless of cross over sequence
- id
- OG001
- title
- Alkeran
- param Type
- GEOMETRIC_MEAN
- population Description
- The pharmacokinetic-evaluable population was defined as all patients who completed dosing and adequate pharmacokinetic blood draws for the calculation of AUC and Cmax for both Melphalan HCl for Injection and Alkeran for Injection. The results are presented by each drug group that combines data from both sequence.
- reporting Status
- POSTED
- time Frame
- Day -3 and Day -2
- title
- Area Under the Curve (0-t)
- type
- PRIMARY
- unit Of Measure
- min*ng/mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice