Trial Outcomes & Findings for Fexofenadine Hydrochloride 180 mg Tablets Under Non-Fasting Conditions (NCT NCT00835640)
NCT ID: NCT00835640
Last Updated: 2009-08-20
Results Overview
Bioequivalence based on Cmax.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Blood samples collected over a 48 hour period.
Results posted on
2009-08-20
Participant Flow
Participant milestones
| Measure |
Fexofenadine Hydrochloride First
180 mg Fexofenadine Hydrochloride Tablets test product dosed in first period followed by 180 mg Allegra® Tablets reference product dosed in the second period.
|
Allegra® First
180 mg Allegra® Tablets reference product dosed in first period followed by 180 mg Fexofenadine Hydrochloride Tablets test product dosed in the second period.
|
|---|---|---|
|
First Intervention
STARTED
|
12
|
12
|
|
First Intervention
COMPLETED
|
12
|
12
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout of 7 Days
STARTED
|
12
|
12
|
|
Washout of 7 Days
COMPLETED
|
12
|
12
|
|
Washout of 7 Days
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
12
|
12
|
|
Second Intervention
COMPLETED
|
11
|
12
|
|
Second Intervention
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Fexofenadine Hydrochloride First
180 mg Fexofenadine Hydrochloride Tablets test product dosed in first period followed by 180 mg Allegra® Tablets reference product dosed in the second period.
|
Allegra® First
180 mg Allegra® Tablets reference product dosed in first period followed by 180 mg Fexofenadine Hydrochloride Tablets test product dosed in the second period.
|
|---|---|---|
|
Second Intervention
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Fexofenadine Hydrochloride 180 mg Tablets Under Non-Fasting Conditions
Baseline characteristics by cohort
| Measure |
Fexofenadine Hydrochloride First
n=12 Participants
180 mg Fexofenadine Hydrochloride Tablets test product dosed in first period followed by 180 mg Allegra® Tablets reference product dosed in the second period.
|
Allegra® First
n=12 Participants
180 mg Allegra® Tablets reference product dosed in first period followed by 180 mg Fexofenadine Hydrochloride Tablets test product dosed in the second period.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over a 48 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Cmax.
Outcome measures
| Measure |
Fexofenadine Hydrochloride
n=23 Participants
180 mg Fexofenadine Hydrochloride Tablets test product dosed in either period.
|
Allegra®
n=23 Participants
180 mg Allegra® Tablets reference product dosed in either period.
|
|---|---|---|
|
Cmax = Maximum Observed Concentration.
|
311.45 ng/mL
Standard Deviation 99.83
|
382.48 ng/mL
Standard Deviation 119.07
|
PRIMARY outcome
Timeframe: Blood samples collected over a 48 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on AUC0-t.
Outcome measures
| Measure |
Fexofenadine Hydrochloride
n=23 Participants
180 mg Fexofenadine Hydrochloride Tablets test product dosed in either period.
|
Allegra®
n=23 Participants
180 mg Allegra® Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (Per Participant)
|
1894.48 ng*h/mL
Standard Deviation 562
|
2159.85 ng*h/mL
Standard Deviation 671.03
|
PRIMARY outcome
Timeframe: Blood samples collected over a 48 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on AUC0-inf.
Outcome measures
| Measure |
Fexofenadine Hydrochloride
n=23 Participants
180 mg Fexofenadine Hydrochloride Tablets test product dosed in either period.
|
Allegra®
n=23 Participants
180 mg Allegra® Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.
|
2061.26 ng*h/mL
Standard Deviation 627.94
|
2324.97 ng*h/mL
Standard Deviation 718.31
|
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 The Principal Investigator is not permitted to discuss or publish trial results.
- Publication restrictions are in place
Restriction type: OTHER