Trial Outcomes & Findings for Leflunomide 20 mg Tablets, Non-Fasting (NCT NCT00834405)
NCT ID: NCT00834405
Last Updated: 2024-08-19
Results Overview
Bioequivalence based on Cmax
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
37 participants
Primary outcome timeframe
Blood samples collected over 72 hour period
Results posted on
2024-08-19
Participant Flow
Participant milestones
| Measure |
Leflunomide
Leflunomide 20 mg Tablet
|
Arava®
Arava® 20 mg Tablet
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
17
|
|
Overall Study
COMPLETED
|
20
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Leflunomide 20 mg Tablets, Non-Fasting
Baseline characteristics by cohort
| Measure |
Leflunomide
n=20 Participants
Leflunomide 20 mg Tablet
|
Arava®
n=17 Participants
Arava® 20 mg Tablet
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
19 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
17 participants
n=107 Participants
|
37 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over 72 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on Cmax
Outcome measures
| Measure |
Leflunomide
n=20 Participants
Leflunomide 20 mg Tablet
|
Arava®
n=17 Participants
Arava® 20 mg Tablet
|
|---|---|---|
|
Cmax - Maximum Observed Concentration - Metabolite A77 1726 in Plasma
|
2488.000 ng/mL
Standard Deviation 385.181
|
2345.294 ng/mL
Standard Deviation 266.156
|
PRIMARY outcome
Timeframe: Blood samples collected over 72 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on AUC0-72
Outcome measures
| Measure |
Leflunomide
n=20 Participants
Leflunomide 20 mg Tablet
|
Arava®
n=17 Participants
Arava® 20 mg Tablet
|
|---|---|---|
|
AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours Post-dose (Per Participant) - Metabolite A77 1726
|
132584.730 ng*h/mL
Standard Deviation 18639.707
|
123335.784 ng*h/mL
Standard Deviation 13732.783
|
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigator is not permitted to discuss or publish trial results.
- Publication restrictions are in place
Restriction type: OTHER