Trial Outcomes & Findings for Fexofenadine Hydrochloride 180 mg Tablets Under Fasting Conditions (NCT NCT00835276)
NCT ID: NCT00835276
Last Updated: 2009-08-20
Results Overview
Bioequivalence based on Cmax.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
60 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
|
24
|
24
|
|
First Intervention
COMPLETED
|
24
|
24
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout of 7 Days
STARTED
|
24
|
24
|
|
Washout of 7 Days
COMPLETED
|
24
|
24
|
|
Washout of 7 Days
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
24
|
24
|
|
Second Intervention
COMPLETED
|
24
|
24
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fexofenadine Hydrochloride 180 mg Tablets Under Fasting Conditions
Baseline characteristics by cohort
| Measure |
Fexofenadine Hydrochloride First
n=24 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=24 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=48 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
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 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
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
22 participants
n=5 Participants
|
24 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
24 participants
n=7 Participants
|
48 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=48 Participants
180 mg Fexofenadine Hydrochloride Tablets test product dosed in either period.
|
Allegra®
n=48 Participants
180 mg Allegra® Tablets reference product dosed in either period.
|
|---|---|---|
|
Cmax = Maximum Observed Concentration.
|
449.6 ng/mL
Standard Deviation 216.08
|
498.95 ng/mL
Standard Deviation 204.3
|
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=48 Participants
180 mg Fexofenadine Hydrochloride Tablets test product dosed in either period.
|
Allegra®
n=48 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)
|
2711.8 ng*h/mL
Standard Deviation 1118.2
|
2912.63 ng*h/mL
Standard Deviation 1092.78
|
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=48 Participants
180 mg Fexofenadine Hydrochloride Tablets test product dosed in either period.
|
Allegra®
n=48 Participants
180 mg Allegra® Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.
|
2814.79 ng*h/mL
Standard Deviation 1132.18
|
3024.53 ng*h/mL
Standard Deviation 1104.18
|
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