Trial Outcomes & Findings for Fed Bioavailability Study of Zonisamide Capsules (NCT NCT00687167)
NCT ID: NCT00687167
Last Updated: 2010-01-26
Results Overview
The maximum or peak concentration that the drug reaches in the plasma.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
34 participants
Primary outcome timeframe
serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 1, 2, 3, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 11, 12, 14, 16, 24, 36, 48, 60 and 72 hours after drug administration.
Results posted on
2010-01-26
Participant Flow
Participant milestones
| Measure |
Zonisamide 100 mg Capsules Then Zonegran® 100 mg Capsules
On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, 30 minutes after the initiation of a standardized, high-fat breakfast, followed by a 28 day washout period. On the morning of Day 29 subjects received one capsule of the reference formulation, Zonegran® 100 mg, 30 minutes after the initiation of a standardized, high-fat breakfast.
|
Zonegran® 100 mg Capsules Then Zonisamide 100 mg Capsules
On the morning of Day 1 subjects received one capsule of the reference formulation, Zonegran® 100 mg, 30 minutes after the initiation of a standardized, high-fat breakfast, followed by a 28 day washout period. On the morning of Day 29 subjects received one capsule of the test formulation, zonisamide 100 mg, 30 minutes after the intiation of a standardized, high-fat breakfast.
|
|---|---|---|
|
First Intervention
STARTED
|
17
|
17
|
|
First Intervention
COMPLETED
|
17
|
17
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout Period of 28 Days
STARTED
|
17
|
17
|
|
Washout Period of 28 Days
COMPLETED
|
17
|
17
|
|
Washout Period of 28 Days
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
17
|
17
|
|
Second Intervention
COMPLETED
|
17
|
17
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fed Bioavailability Study of Zonisamide Capsules
Baseline characteristics by cohort
| Measure |
Zonisamide 100 mg Capsules and Zonegran® 100 mg Capsules
n=34 Participants
All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 29, each subject received one capsule of either zonisamide 100 mg or Zonegran® 100 mg, 30 minutes after the initiation of a standardized, high-fat breakfast preceeded by an overnight fast.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
27.7 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 1, 2, 3, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 11, 12, 14, 16, 24, 36, 48, 60 and 72 hours after drug administration.The maximum or peak concentration that the drug reaches in the plasma.
Outcome measures
| Measure |
Zonisamide 100 mg Capsules
n=34 Participants
On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, 30 minutes after the intiation of a standardized, high-fat breakfast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen 30 minutes after the initiation of a standardized, high-fat breakfast.
|
Zonegran® 100 mg Capsules
n=34 Participants
On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, 30 minutes after the intiation of a standardized, high-fat breakfast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen 30 minutes after the initiation of a standardized, high-fat breakfast.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
910.95 ng/mL
Standard Deviation 226.80
|
921.68 ng/mL
Standard Deviation 220.64
|
PRIMARY outcome
Timeframe: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 1, 2, 3, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 11, 12, 14, 16, 24, 36, 48, 60 and 72 hours after drug administration.The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.
Outcome measures
| Measure |
Zonisamide 100 mg Capsules
n=34 Participants
On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, 30 minutes after the intiation of a standardized, high-fat breakfast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen 30 minutes after the initiation of a standardized, high-fat breakfast.
|
Zonegran® 100 mg Capsules
n=34 Participants
On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, 30 minutes after the intiation of a standardized, high-fat breakfast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen 30 minutes after the initiation of a standardized, high-fat breakfast.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
|
40,122.78 ng-hr/mL
Standard Deviation 7,937.88
|
40,275.57 ng-hr/mL
Standard Deviation 8,429.48
|
Adverse Events
Zonisamide 100 mg Capsules
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Zonegran® 100 mg Capsules
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Zonisamide 100 mg Capsules
n=34 participants at risk
All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 29, each subject received one capsule of either zonisamide 100 mg or Zonegran® 100 mg, 30 minutes after the initiation of a standardized, high-fat breakfast preceeded by an overnight fast.
|
Zonegran® 100 mg Capsules
n=34 participants at risk
All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 29, each subject received one capsule of either zonisamide 100 mg or Zonegran® 100 mg, 30 minutes after the initiation of a standardized, high-fat breakfast preceeded by an overnight fast.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/34
|
2.9%
1/34 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/34
|
2.9%
1/34 • Number of events 1
|
|
Infections and infestations
Influenza like illness
|
0.00%
0/34
|
2.9%
1/34 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
2.9%
1/34 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/34
|
5.9%
2/34 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60