Trial · NCT04425902
Outcomes171
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 171
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Time t (AUC[0-t]) for Caffeine | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | The Pharmacokinetic (PK) Parameter Population included all participants who underwent plasma PK sampling and had evaluable PK parameters estimated. Only those participants with data available at the specified time points were analyzed. | Hour*nanograms per milliliter (h*ng/mL) | GEOMETRIC_MEAN |
| PRIMARY | AUC From Time Zero Extrapolated to Infinity (AUC[0-infinity]) for Caffeine | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | h*ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Maximum Observed Plasma Concentration (Cmax) for Caffeine | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | Nanograms per milliliter (ng/mL) | GEOMETRIC_MEAN |
| PRIMARY | Time to Cmax (Tmax) for Caffeine | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | Hours | MEDIAN |
| PRIMARY | Apparent Terminal Phase Half-life (t1/2) for Caffeine | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | Hours | GEOMETRIC_MEAN |
| PRIMARY | AUC(0-t) for Metoprolol | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | h*ng/mL | GEOMETRIC_MEAN |
| PRIMARY | AUC(0-infinity) for Metoprolol | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | h*ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Cmax for Metoprolol | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Tmax for Metoprolol | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | Hours | MEDIAN |
| PRIMARY | t1/2 for Metoprolol | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | Hours | GEOMETRIC_MEAN |
| PRIMARY | AUC(0-t) for Montelukast | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | h*ng/mL | GEOMETRIC_MEAN |
| PRIMARY | AUC(0-infinity) for Montelukast | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | h*ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Cmax for Montelukast | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | Nanograms per milliliter (ng/mL) | GEOMETRIC_MEAN |
| PRIMARY | Tmax for Montelukast | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | Hours | MEDIAN |
| PRIMARY | t1/2 for Montelukast | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | Hours | GEOMETRIC_MEAN |
| PRIMARY | AUC(0-t) for Flurbiprofen | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | h*ng/mL | GEOMETRIC_MEAN |
| PRIMARY | AUC(0-infinity) for Flurbiprofen | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | h*ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Cmax for Flurbiprofen | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Tmax for Flurbiprofen | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | Hours | MEDIAN |
| PRIMARY | t1/2 for Flurbiprofen | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | Hours | GEOMETRIC_MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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