Trial Outcomes & Findings for Famciclovir 500 mg Tablets Under Fasting Conditions (NCT NCT00834431)
NCT ID: NCT00834431
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
|
18
|
17
|
|
First Intervention
NOT COMPLETED
|
0
|
1
|
|
Washout of 7 Days
STARTED
|
18
|
17
|
|
Washout of 7 Days
COMPLETED
|
18
|
16
|
|
Washout of 7 Days
NOT COMPLETED
|
0
|
1
|
|
Second Intervention
STARTED
|
18
|
16
|
|
Second Intervention
COMPLETED
|
18
|
16
|
|
Second Intervention
NOT COMPLETED
|
0
|
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
|
0
|
1
|
|
Washout of 7 Days
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Famciclovir 500 mg Tablets Under 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
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
13 participants
n=5 Participants
|
16 participants
n=7 Participants
|
29 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.
Bioequivalence based on Cmax.
Outcome measures
| Measure |
Famciclovir
n=34 Participants
500 mg Famciclovir Tablets test product dosed in either period.
|
Famvir®
n=34 Participants
500 mg Famvir® Tablets reference product dosed in either period.
|
|---|---|---|
|
Cmax = Maximum Observed Concentration.
|
3265.647 ng/mL
Standard Deviation 954.529
|
3521.118 ng/mL
Standard Deviation 876.23
|
PRIMARY outcome
Timeframe: Blood samples collected over a 16 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on AUC0-t.
Outcome measures
| Measure |
Famciclovir
n=34 Participants
500 mg Famciclovir Tablets test product dosed in either period.
|
Famvir®
n=34 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)
|
10022.244 ng*h/mL
Standard Deviation 1604.383
|
10200.015 ng*h/mL
Standard Deviation 1703.293
|
PRIMARY outcome
Timeframe: Blood samples collected over a 16 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on AUC0-inf.
Outcome measures
| Measure |
Famciclovir
n=34 Participants
500 mg Famciclovir Tablets test product dosed in either period.
|
Famvir®
n=34 Participants
500 mg Famvir® Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.
|
10135.731 ng*h/mL
Standard Deviation 1604.773
|
10305.772 ng*h/mL
Standard Deviation 1702.728
|
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