TriangleNCT03085095 · OUTCOME
Time To Maximum Observed Plasma Concentration (Tmax) Of Relugolix
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
- Predose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours postdose on Day 1 and Week 2
What was measured
The Tmax of relugolix was determined for single and repeat doses in subsets of participants from Japan. Single dose PK was assessed on Day 1 following an initial 360 mg dose of relugolix. Repeat dose PK was assessed following repeat dosing of relugolix 120 mg once daily for 2 weeks.
Analysis population: A subset of Japanese participants enrolled in study were included in the PK analysis.
Groups in this outcome
Relugolix Single-Dose
Relugolix oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
Relugolix Repeat-Dose
Relugolix 120-mg tablet administered orally once daily for 2 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
| Group | Source count |
|---|---|
| Relugolix Single-Dose | 7 |
| Relugolix Repeat-Dose | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Relugolix Single-Dose | 1.03 | Not reported | 0.400 | 4.05 | Not reported |
| Relugolix Repeat-Dose | 0.983 | Not reported | 0.433 | 4.08 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.400
- upper Limit
- 4.05
- value
- 1.03
- group Id
- OG001
- lower Limit
- 0.433
- upper Limit
- 4.08
- value
- 0.983
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 7
- units
- Participants
- description
- The Tmax of relugolix was determined for single and repeat doses in subsets of participants from Japan. Single dose PK was assessed on Day 1 following an initial 360 mg dose of relugolix. Repeat dose PK was assessed following repeat dosing of relugolix 120 mg once daily for 2 weeks.
- dispersion Type
- Full Range
- groups
- description
- Relugolix oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
- id
- OG000
- title
- Relugolix Single-Dose
- description
- Relugolix 120-mg tablet administered orally once daily for 2 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
- id
- OG001
- title
- Relugolix Repeat-Dose
- param Type
- MEDIAN
- population Description
- A subset of Japanese participants enrolled in study were included in the PK analysis.
- reporting Status
- POSTED
- time Frame
- Predose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours postdose on Day 1 and Week 2
- title
- Time To Maximum Observed Plasma Concentration (Tmax) Of Relugolix
- type
- SECONDARY
- unit Of Measure
- hours
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice