Trial Outcomes & Findings for Leflunomide 20 mg Tablets Under Fasting Conditions (NCT NCT00834418)
NCT ID: NCT00834418
Last Updated: 2024-08-20
Results Overview
Bioequivalence based on Cmax
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
84 participants
Primary outcome timeframe
Blood samples collected over 72 hour period
Results posted on
2024-08-20
Participant Flow
Participant milestones
| Measure |
Leflunomide
Leflunomide 20 mg Tablet
|
Arava™
Arava™ 20 mg Tablet
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
42
|
|
Overall Study
COMPLETED
|
42
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Leflunomide
Leflunomide 20 mg Tablet
|
Arava™
Arava™ 20 mg Tablet
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
Baseline Characteristics
Leflunomide 20 mg Tablets Under Fasting Conditions
Baseline characteristics by cohort
| Measure |
Leflunomide
n=42 Participants
Leflunomide 20 mg Tablet
|
Arava™
n=42 Participants
Arava™ 20 mg Tablet
|
Total
n=84 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
|
38 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
76 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
40 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=99 Participants
|
42 participants
n=107 Participants
|
84 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=42 Participants
Leflunomide 20 mg Tablet
|
Arava™
n=40 Participants
Arava™ 20 mg Tablet
|
|---|---|---|
|
Cmax - Maximum Observed Concentration - Metabolite A77 1726 in Plasma
|
2109.286 ng/mL
Standard Deviation 407.044
|
1974.000 ng/mL
Standard Deviation 421.291
|
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=42 Participants
Leflunomide 20 mg Tablet
|
Arava™
n=40 Participants
Arava™ 20 mg Tablet
|
|---|---|---|
|
AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours Post-dose - Metabolite A77 1726
|
105806.888 ng*h/mL
Standard Deviation 19068.308
|
103905.901 ng*h/mL
Standard Deviation 19933.702
|
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