Trial · NCT00834418
Leflunomide 20 mg Tablets Under Fasting Conditions
NCT00834418, Phase 1, Completed, Teva Pharmaceuticals USA; results first posted 2009-08-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Leflunomide 20 mg Tablets Under Fasting Conditions. Trials, record NCT00834418. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00834418
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Leflunomide 20 mg Tablets Under Fasting Conditions
- NCT number
- NCT00834418
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 84 participants, actual
- Lead sponsor
- Teva Pharmaceuticals USA
- Conditions
- Healthy
- Interventions
- Leflunomide 20 mg Tablets, ARAVA™ 20 mg Tablets
- First posted
- 2009-02-03
- Last updated
- 2024-08-20
- Results first posted
- 2009-08-18
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cmax - Maximum Observed Concentration - Metabolite A77 1726 in Plasma | Blood samples collected over 72 hour period | Bioequivalence based on Cmax |
| Primary | AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours Post-dose - Metabolite A77 1726 | Blood samples collected over 72 hour period | Bioequivalence based on AUC0-72 |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cmax - Maximum Observed Concentration - Metabolite A77 1726 in Plasma | Blood samples collected over 72 hour period | Data from all subjects who completed the study were included in the statistical analysis. | ng/mL | MEAN |
| PRIMARY | AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours Post-dose - Metabolite A77 1726 | Blood samples collected over 72 hour period | Data from all subjects who completed the study were included in the statistical analysis. | ng*h/mL | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cmax - Maximum Observed Concentration - Metabolite A77 1726 in Plasma | Leflunomide | 2109.286 | Standard Deviation 407.044 | ng/mL | |
| Cmax - Maximum Observed Concentration - Metabolite A77 1726 in Plasma | Arava™ | 1974.000 | Standard Deviation 421.291 | ng/mL | |
| AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours Post-dose - Metabolite A77 1726 | Leflunomide | 105806.888 | Standard Deviation 19068.308 | ng*h/mL | |
| AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours Post-dose - Metabolite A77 1726 | Arava™ | 103905.901 | Standard Deviation 19933.702 | ng*h/mL |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Leflunomide | 42 | |
| Overall Study | STARTED | Arava™ | 42 | |
| Overall Study | COMPLETED | Leflunomide | 42 | |
| Overall Study | COMPLETED | Arava™ | 40 | |
| Overall Study | NOT COMPLETED | Leflunomide | 0 | |
| Overall Study | NOT COMPLETED | Arava™ | 2 |
Source ClinicalTrials.gov
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/NCT00834418
GET https://conductscience.org/api/trials/v1/NCT00834418/registered