TriangleNCT02365597 · OUTCOME
Drug-Drug Interaction (DDI) Substudy: Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Metformin Alone or in Combination With Erdafitinib
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
- Cycle 1 Day -1 (predose) up to Day 14 post dose (each cycle length=28 days)
What was measured
Tmax is the time to reach maximum observed plasma concentration of metformin alone or in combination with erdafitinib
Analysis population: Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Groups in this outcome
DDI Study: Metformin 1000 mg Alone
Participants received single dose of metformin 1000 mg tablet, orally, once daily, starting from Day -1 through Day 14 of Cycle 1 (each cycle length=28 days).
DDI Study: Metformin 1000 mg + Erdafitinib 8 mg
Participants received single dose of metformin 1000 mg tablet, orally, once daily, starting from Day -1 through Day 14 of Cycle 1 along with erdafitinib 8 mg starting from Day 1 up to Day 15 of Cycle 1 (each cycle length=28 days).
| Group | Source count |
|---|---|
| DDI Study: Metformin 1000 mg Alone | 20 |
| DDI Study: Metformin 1000 mg + Erdafitinib 8 mg | 19 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| DDI Study: Metformin 1000 mg Alone | 2.04 | Not reported | 0.42 | 5.00 | Not reported |
| DDI Study: Metformin 1000 mg + Erdafitinib 8 mg | 3.00 | Not reported | 0.50 | 8.08 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.42
- upper Limit
- 5.00
- value
- 2.04
- group Id
- OG001
- lower Limit
- 0.50
- upper Limit
- 8.08
- value
- 3.00
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 19
- units
- Participants
- description
- Tmax is the time to reach maximum observed plasma concentration of metformin alone or in combination with erdafitinib
- dispersion Type
- Full Range
- groups
- description
- Participants received single dose of metformin 1000 mg tablet, orally, once daily, starting from Day -1 through Day 14 of Cycle 1 (each cycle length=28 days).
- id
- OG000
- title
- DDI Study: Metformin 1000 mg Alone
- description
- Participants received single dose of metformin 1000 mg tablet, orally, once daily, starting from Day -1 through Day 14 of Cycle 1 along with erdafitinib 8 mg starting from Day 1 up to Day 15 of Cycle 1 (each cycle length=28 days).
- id
- OG001
- title
- DDI Study: Metformin 1000 mg + Erdafitinib 8 mg
- param Type
- MEDIAN
- population Description
- Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day -1 (predose) up to Day 14 post dose (each cycle length=28 days)
- title
- Drug-Drug Interaction (DDI) Substudy: Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Metformin Alone or in Combination With Erdafitinib
- type
- PRIMARY
- unit Of Measure
- Hours
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice