Trial · NCT01322282
To Test Bioequivalence Between Two Tablet Formulations in the Treatment of Allergy
NCT01322282, Phase 1, Completed, McNeil AB
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. To Test Bioequivalence Between Two Tablet Formulations in the Treatment of Allergy. Trials, record NCT01322282. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01322282
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- To Test Bioequivalence Between Two Tablet Formulations in the Treatment of Allergy
- NCT number
- NCT01322282
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 36 participants, actual
- Lead sponsor
- McNeil AB
- Conditions
- Allergy
- Interventions
- Cetirizine, Cetirizine
- First posted
- 2011-03-24
- Last updated
- 2012-07-10
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 | During 32 hours post-dose | Maximum Observed Plasma Concentration (Cmax), which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered, measured in nanograms/milliliter (ng/mL) |
| Primary | Bioavailability [AUC(0-t)] | During 32 hours post-dose | Bioavailability \[AUC(0-t)\] is a measure of how much of the drug reaches the person's bloodstream within a given period of time for the body to use. The extent of product bioavailability is estimated by the area under the blood concentration vs time curve. The Area Under the Curve (AUC) is calculated by plotting the drug's blood levels on a graph at different times during the set period. The area under this curve reflects the amount of drug exposure in the set time period, calculated as hour \* nanograms (ng) per milliliter (mL). |
| Primary | Bioavailability Extrapolated to Infinity [AUC (0-∞)] | 32 hours post-dose | Bioavailability Extrapolated to Infinity \[AUC (0-∞)\] is a calculated measure of how much of the drug will ever reach the person's bloodstream for the body to use. AUC (0-∞) stands for the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (forever). It is obtained from calculating AUC (0-t) plus AUC (t-∞). |
| Secondary | Time of Maximum Concentration | During 32 hours post-dose | The time at which maximum concentration is reached (Tmax) |
| Secondary | Terminal Elimination Rate Constant | During 32 hours post-dose | The Terminal Elimination Rate Constant (Lamda z) is the time required to eliminate half the administered dose |
| Secondary | Terminal Phase Plasma Half-Life | During 32 hours post-dose | Terminal phase plasma half-life (t ½) is the time required to divide the plasma concentration by two after reaching pseudo-equilibrium, rather than the time required to eliminate half the administered dose. |
| Secondary | Area under the Curve to the Tmax of the Reference Products | During 32 hours post-dose | Area under the plasma concentration versus time curve to the time of the maximum concentration of the reference products (AUCReftmax) |
| Secondary | Relative percentage of AUCT with respect to AUC∞ (AUCT/∞) | During 32 hours post-dose | AUCT is the area under the plasma concentration verses time curve from start of drug administration until the time of the last measurable plasma concentration. AUC∞ is the area under the plasma concentration versus time curve from start of drug administration until extrapolated infinite time. AUCT/ AUC∞ is an inversed measure of how large the extrapolated area under the curve is. |
| Secondary | Mean Residence Time | During 32 hours post-dose | The average amount of time a particle (e.g., a drug substance molecule) remains in a compartment or system. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01322282
GET https://conductscience.org/api/trials/v1/NCT01322282/registered