Trial Outcomes & Findings for Valacyclovir 1000 mg Tablet Under Fed Conditions (NCT NCT01149460)
NCT ID: NCT01149460
Last Updated: 2024-08-21
Results Overview
Bioequivalence based on Cmax
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
Blood samples collected over 12 hour period
Results posted on
2024-08-21
Participant Flow
Participant milestones
| Measure |
Valacyclovir
Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
|
Valtrex®
Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
18
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Valacyclovir
Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
|
Valtrex®
Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Valacyclovir 1000 mg Tablet Under Fed Conditions
Baseline characteristics by cohort
| Measure |
Valacyclovir
n=18 Participants
Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
|
Valtrex®
n=18 Participants
Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in 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
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over 12 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on Cmax
Outcome measures
| Measure |
Valacyclovir
n=18 Participants
Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
|
Valtrex®
n=16 Participants
Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
|
|---|---|---|
|
Cmax (Maximum Observed Concentration of Drug Substance in Plasma) - Valacyclovir
|
385.35 ng/mL
Standard Deviation 139.10
|
350.86 ng/mL
Standard Deviation 133.20
|
PRIMARY outcome
Timeframe: Blood samples collected over 12 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on AUC0-t
Outcome measures
| Measure |
Valacyclovir
n=18 Participants
Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
|
Valtrex®
n=16 Participants
Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
|
|---|---|---|
|
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) - Valacyclovir
|
549.32 ng*h/mL
Standard Deviation 137.87
|
551.77 ng*h/mL
Standard Deviation 140.73
|
PRIMARY outcome
Timeframe: Blood samples collected over 12 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on AUC0-inf
Outcome measures
| Measure |
Valacyclovir
n=18 Participants
Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
|
Valtrex®
n=16 Participants
Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
|
|---|---|---|
|
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) - Valacyclovir
|
552.17 ng*h/mL
Standard Deviation 138.76
|
554.53 ng*h/mL
Standard Deviation 140.97
|
SECONDARY outcome
Timeframe: Blood samples collected over 24 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Outcome measures
| Measure |
Valacyclovir
n=18 Participants
Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
|
Valtrex®
n=16 Participants
Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
|
|---|---|---|
|
Cmax (Maximum Observed Concentration of Drug Substance in Plasma) - Acyclovir
|
6485.51 ng/mL
Standard Deviation 1469.43
|
6283.25 ng/mL
Standard Deviation 1375.42
|
SECONDARY outcome
Timeframe: Blood samples collected over 24 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Outcome measures
| Measure |
Valacyclovir
n=18 Participants
Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
|
Valtrex®
n=16 Participants
Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
|
|---|---|---|
|
AUC0-t (Area Under Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) - Acyclovir
|
22514.36 ng*h/mL
Standard Deviation 4316.76
|
22675.85 ng*h/mL
Standard Deviation 4063.20
|
SECONDARY outcome
Timeframe: Blood samples collected over 24 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Outcome measures
| Measure |
Valacyclovir
n=18 Participants
Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
|
Valtrex®
n=16 Participants
Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
|
|---|---|---|
|
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) - Acyclovir
|
22705.17 ng*h/mL
Standard Deviation 4336.16
|
22887.99 ng*h/mL
Standard Deviation 4065.19
|
Adverse Events
Valacyclovir
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Valtrex®
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Valacyclovir
n=36 participants at risk
Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
|
Valtrex®
n=36 participants at risk
Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
|
|---|---|---|
|
Nervous system disorders
Headache
|
5.6%
2/36 • Number of events 2
|
11.1%
4/36 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal Pain/Cramp
|
0.00%
0/36
|
11.1%
4/36 • Number of events 4
|
|
Gastrointestinal disorders
Loose/Soft Stools
|
2.8%
1/36 • Number of events 1
|
5.6%
2/36 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.8%
1/36 • Number of events 1
|
8.3%
3/36 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/36
|
5.6%
2/36 • Number of events 2
|
|
Blood and lymphatic system disorders
Low Hemoglobin Level
|
5.6%
2/36 • Number of events 2
|
2.8%
1/36 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
8.3%
3/36 • Number of events 3
|
5.6%
2/36 • Number of events 3
|
|
General disorders
Fatigue/Drowsiness
|
0.00%
0/36
|
5.6%
2/36 • Number of events 2
|
Additional Information
Associate Director, Biopharmaceutics
Teva Pharmaceuticals USA
Phone: 1-866-384-5525
Email: [email protected]
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