Trial Outcomes & Findings for Famciclovir 500 mg Tablets Under Non-Fasting Conditions (NCT NCT00834444)
NCT ID: NCT00834444
Last Updated: 2024-08-20
Results Overview
Bioequivalence based on Cmax.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
Blood samples collected over a 16 hour period.
Results posted on
2024-08-20
Participant Flow
Participant milestones
| Measure |
Famciclovir First
500 mg Famciclovir Tablets test product dosed in first period followed by 500 mg Famvir® Tablets reference product dosed in the second period.
|
Famvir® First
500 mg Famvir® Tablets reference product dosed in first period followed by 500 mg Famciclovir Tablets test product dosed in the second period.
|
|---|---|---|
|
First Intervention
STARTED
|
18
|
18
|
|
First Intervention
COMPLETED
|
17
|
17
|
|
First Intervention
NOT COMPLETED
|
1
|
1
|
|
Washout of 7 Days
STARTED
|
17
|
17
|
|
Washout of 7 Days
COMPLETED
|
17
|
16
|
|
Washout of 7 Days
NOT COMPLETED
|
0
|
1
|
|
Second Intervention
STARTED
|
17
|
16
|
|
Second Intervention
COMPLETED
|
16
|
16
|
|
Second Intervention
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Famciclovir First
500 mg Famciclovir Tablets test product dosed in first period followed by 500 mg Famvir® Tablets reference product dosed in the second period.
|
Famvir® First
500 mg Famvir® Tablets reference product dosed in first period followed by 500 mg Famciclovir Tablets test product dosed in the second period.
|
|---|---|---|
|
First Intervention
Adverse Event
|
1
|
0
|
|
First Intervention
Intolerance to Venopuncture
|
0
|
1
|
|
Washout of 7 Days
Withdrawal by Subject
|
0
|
1
|
|
Second Intervention
Adverse Event
|
1
|
0
|
Baseline Characteristics
Famciclovir 500 mg Tablets Under Non-Fasting Conditions
Baseline characteristics by cohort
| Measure |
Famciclovir First
n=18 Participants
500 mg Famciclovir Tablets test product dosed in first period followed by 500 mg Famvir® Tablets reference product dosed in the second period.
|
Famvir® First
n=18 Participants
500 mg Famvir® Tablets reference product dosed in first period followed by 500 mg Famciclovir Tablets test product dosed in the second period.
|
Total
n=36 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
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 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
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
14 participants
n=5 Participants
|
15 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over a 16 hour period.Population: All participants that completed the study had their samples analyzed. Data from one withdrawn subject was also included in the statistical analysis.
Bioequivalence based on Cmax.
Outcome measures
| Measure |
Famciclovir
n=33 Participants
500 mg Famciclovir Tablets test product dosed in either period.
|
Famvir®
n=33 Participants
500 mg Famvir® Tablets reference product dosed in either period.
|
|---|---|---|
|
Cmax = Maximum Observed Concentration.
|
2557.03 ng/mL
Standard Deviation 473.169
|
2713.939 ng/mL
Standard Deviation 757.822
|
PRIMARY outcome
Timeframe: Blood samples collected over a 16 hour period.Population: All participants that completed the study had their samples analyzed. Data from one withdrawn subject was also included in the statistical analysis.
Bioequivalence based on AUC0-t.
Outcome measures
| Measure |
Famciclovir
n=33 Participants
500 mg Famciclovir Tablets test product dosed in either period.
|
Famvir®
n=33 Participants
500 mg Famvir® 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)
|
9568.663 ng*h/mL
Standard Deviation 1944.418
|
9533.607 ng*h/mL
Standard Deviation 1816.697
|
PRIMARY outcome
Timeframe: Blood samples collected over a 16 hour period.Population: All participants that completed the study had their samples analyzed. Data from one withdrawn subject was also included in the statistical analysis.
Bioequivalence based on AUC0-inf.
Outcome measures
| Measure |
Famciclovir
n=33 Participants
500 mg Famciclovir Tablets test product dosed in either period.
|
Famvir®
n=33 Participants
500 mg Famvir® Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.
|
9685.718 ng*h/mL
Standard Deviation 1952.136
|
9660.396 ng*h/mL
Standard Deviation 1820.452
|
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