Trial · NCT02629354
To Determine Blood Concentrations of Ibuprofen and Caffeine in a Tablet Against Ibuprofen Alone From Another Tablet
NCT02629354, Phase 1, Completed, Boehringer Ingelheim; results first posted 2017-03-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. To Determine Blood Concentrations of Ibuprofen and Caffeine in a Tablet Against Ibuprofen Alone From Another Tablet. Trials, record NCT02629354. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02629354
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- To Determine Blood Concentrations of Ibuprofen and Caffeine in a Tablet Against Ibuprofen Alone From Another Tablet
- NCT number
- NCT02629354
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 36 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Healthy
- Interventions
- Ibuprofen, Caffeine, Ibuprofen
- First posted
- 2015-12-14
- Last updated
- 2017-05-05
- Results first posted
- 2017-03-16
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Observed Plasma Concentration (Cmax) of S-ibuprofen | Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose | This outcome measure presents the maximum observed concentration (Cmax) of S-ibuprofen in plasma obtained directly from the concentration-time data. |
| Primary | Cmax of R-ibuprofen | Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose | This outcome measure presents the Cmax of R-ibuprofen in plasma obtained directly from the concentration-time data. |
| Primary | Cmax of Ibuprofen | Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose | This outcome measure presents the Cmax of ibuprofen in plasma obtained directly from the concentration-time data. |
| Primary | Area Under the Plasma Concentration of S-ibuprofen Versus Time Curve, From Time Zero to t (AUC0-t) | Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose | This outcome measure presents the area under the plasma concentration of S-ibuprofen versus time curve, from time zero to t, where t is the time of the last quantifiable concentration (AUC0-t). |
| Primary | AUC0-t of R-ibuprofen | Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose | This outcome measure presents the area under the plasma concentration of R-ibuprofen versus time curve, from time zero to t, where t is the time of the last quantifiable concentration (AUC0-t). |
| Primary | AUC0-t of Ibuprofen | Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose | This outcome measure presents the area under the plasma concentration of ibuprofen versus time curve, from time zero to t, where t is the time of the last quantifiable concentration (AUC0-t). |
| Secondary | Area Under the Plasma Concentration of S-ibuprofen Versus Time Curve, With Extrapolation to Infinity (AUC0-INF) | Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose | This outcome measure presents the area under the plasma concentration of S-ibuprofen versus time curve, with extrapolation to infinity (AUC0-INF). |
| Secondary | AUC0-INF of R-ibuprofen | Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose | This outcome measure presents the area under the plasma concentration of R-ibuprofen versus time curve, with extrapolation to infinity (AUC0-INF). |
| Secondary | AUC0-INF of Ibuprofen | Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose | This outcome measure presents the area under the plasma concentration of ibuprofen versus time curve, with extrapolation to infinity (AUC0-INF). |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Observed Plasma Concentration (Cmax) of S-ibuprofen | Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose | Pharmacokinetic (PK) population: all subjects who completed the PK sampling in both periods and with no major protocol deviations considered to impact on the analysis of the PK data were included. | nanogram (ng)/ millilitre (mL) | GEOMETRIC_MEAN |
| PRIMARY | Cmax of R-ibuprofen | Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose | PK population | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Cmax of Ibuprofen | Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose | PK population | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Area Under the Plasma Concentration of S-ibuprofen Versus Time Curve, From Time Zero to t (AUC0-t) | Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose | PK population | hour (h)*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Plasma Concentration of S-ibuprofen Versus Time Curve, With Extrapolation to Infinity (AUC0-INF) | Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose | PK population | h*ng/mL | GEOMETRIC_MEAN |
| PRIMARY | AUC0-t of R-ibuprofen | Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose | PK population | h*ng/mL | GEOMETRIC_MEAN |
| PRIMARY | AUC0-t of Ibuprofen | Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose | PK population | h*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | AUC0-INF of R-ibuprofen | Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose | PK population | h*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | AUC0-INF of Ibuprofen | Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose | PK population | h*ng/mL | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of S-ibuprofen | Reference Product | 13268.7 | Geometric Coefficient of Variation 38.0 | nanogram (ng)/ millilitre (mL) | |
| Maximum Observed Plasma Concentration (Cmax) of S-ibuprofen | Test Product | 14967.2 | Geometric Coefficient of Variation 34.9 | nanogram (ng)/ millilitre (mL) | |
| Cmax of R-ibuprofen | Reference Product | 10495.7 | Geometric Coefficient of Variation 32.7 | ng/mL | |
| Cmax of R-ibuprofen | Test Product | 11454.6 | Geometric Coefficient of Variation 26.6 | ng/mL | |
| Cmax of Ibuprofen | Reference Product | 23557.9 | Geometric Coefficient of Variation 34.8 | ng/mL | |
| Cmax of Ibuprofen | Test Product | 26309.5 | Geometric Coefficient of Variation 30.3 | ng/mL | |
| Area Under the Plasma Concentration of S-ibuprofen Versus Time Curve, From Time Zero to t (AUC0-t) | Reference Product | 65110 | Geometric Coefficient of Variation 21.9 | hour (h)*ng/mL | |
| Area Under the Plasma Concentration of S-ibuprofen Versus Time Curve, From Time Zero to t (AUC0-t) | Test Product | 63150 | Geometric Coefficient of Variation 21.7 | hour (h)*ng/mL | |
| Area Under the Plasma Concentration of S-ibuprofen Versus Time Curve, With Extrapolation to Infinity (AUC0-INF) | Reference Product | 68900 | Geometric Coefficient of Variation 17.2 | h*ng/mL | |
| Area Under the Plasma Concentration of S-ibuprofen Versus Time Curve, With Extrapolation to Infinity (AUC0-INF) | Test Product | 64990 | Geometric Coefficient of Variation 20.6 | h*ng/mL |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 | STARTED | Ref - Test | 18 | |
| Period 1 | STARTED | Test - Ref | 18 | |
| Period 1 | COMPLETED | Ref - Test | 18 | |
| Period 1 | COMPLETED | Test - Ref | 18 | |
| Period 1 | NOT COMPLETED | Ref - Test | 0 | |
| Period 1 | NOT COMPLETED | Test - Ref | 0 | |
| Washout Period | STARTED | Ref - Test | 18 | |
| Washout Period | STARTED | Test - Ref | 18 | |
| Washout Period | COMPLETED | Ref - Test | 18 | |
| Washout Period | COMPLETED | Test - Ref | 18 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Reference Product | ||
| Total, all-cause mortality | Test Product | ||
| Total, other adverse events | Reference Product | 0 | 36 |
| Total, other adverse events | Test Product | 0 | 36 |
| Total, serious adverse events | Reference Product | 0 | 36 |
| Total, serious adverse events | Test Product | 0 | 36 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Reference Product vs Test Product: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02629354
GET https://conductscience.org/api/trials/v1/NCT02629354/flow?page=2