Trial Outcomes & Findings for Divalproex Sodium Delayed-Release Tablets Under Non-Fasting Conditions (NCT NCT00834990)
NCT ID: NCT00834990
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 72 hour period.
Results posted on
2009-08-20
Participant Flow
Participant milestones
| Measure |
Divalproex Sodium First
500 mg Divalproex Sodium Delayed Release Tablets test product dosed in first period followed by 500 mg Depakote® Delayed Release Tablets reference product dosed in the second period.
|
Depakote® First
500 mg Depakote® Delayed Release Tablets reference product dosed in first period followed by 500 mg Divalproex Sodium Delayed Release Tablets test product dosed in the second period.
|
|---|---|---|
|
First Intervention
STARTED
|
12
|
11
|
|
First Intervention
COMPLETED
|
12
|
11
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout of 7 Days
STARTED
|
12
|
11
|
|
Washout of 7 Days
COMPLETED
|
12
|
11
|
|
Washout of 7 Days
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
12
|
11
|
|
Second Intervention
COMPLETED
|
12
|
11
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Divalproex Sodium Delayed-Release Tablets Under Non-Fasting Conditions
Baseline characteristics by cohort
| Measure |
Divalproex Sodium First
n=12 Participants
500 mg Divalproex Sodium Delayed Release Tablets test product dosed in first period followed by 500 mg Depakote® Delayed Release Tablets reference product dosed in the second period.
|
Depakote® First
n=11 Participants
500 mg Depakote® Delayed Release Tablets reference product dosed in first period followed by 500 mg Divalproex Sodium Delayed Release Tablets test product dosed in the second period.
|
Total
n=23 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
|
11 Participants
n=7 Participants
|
23 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over a 72 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Cmax.
Outcome measures
| Measure |
Divalproex Sodium
n=23 Participants
500 mg Divalproex Sodium Delayed Release Tablets test product dosed in either period.
|
Depakote®
n=23 Participants
500 mg Depakote® Delayed Release Tablets reference product dosed in either period.
|
|---|---|---|
|
Cmax (Maximum Observed Concentration)
|
49.02 µg/mL
Standard Deviation 7.61
|
47.83 µg/mL
Standard Deviation 9.57
|
PRIMARY outcome
Timeframe: Blood samples collected over a 72 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on AUC0-t.
Outcome measures
| Measure |
Divalproex Sodium
n=23 Participants
500 mg Divalproex Sodium Delayed Release Tablets test product dosed in either period.
|
Depakote®
n=23 Participants
500 mg Depakote® Delayed Release Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
|
934.87 µg*h/mL
Standard Deviation 193.26
|
917.11 µg*h/mL
Standard Deviation 192.97
|
PRIMARY outcome
Timeframe: Blood samples collected over a 72 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on AUC0-inf.
Outcome measures
| Measure |
Divalproex Sodium
n=23 Participants
500 mg Divalproex Sodium Delayed Release Tablets test product dosed in either period.
|
Depakote®
n=23 Participants
500 mg Depakote® Delayed Release Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
|
1024.72 µg*h/mL
Standard Deviation 223.2
|
991.74 µg*h/mL
Standard Deviation 224
|
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