Trial Outcomes & Findings for Fasted Bioequivalence Study of Primidone Tablets and Mysoline Tablets (NCT NCT00685165)
NCT ID: NCT00685165
Last Updated: 2010-01-20
Results Overview
The maximum or peak concentration that the drug reaches in the plasma.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
22 participants
Primary outcome timeframe
serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours after drug administration.
Results posted on
2010-01-20
Participant Flow
Participant milestones
| Measure |
Primidone 50 mg Tablets Then Mysoline® 50 mg Tablets
On the morning of Day 1 subjects received one tablet of the test formulation, primidone 50 mg, after an overnight fast of at least 10 hours, followed by a 14 day washout period. On the morning of Day 15 subjects received one tablet of the reference formulation, Mysoline® 50 mg, after an overnight fast of at least 10 hours.
|
Mysoline® 50 mg Tablets Then Primidone 50 mg Tablets
On the morning of Day 1 subjects received one tablet of the reference formulation, Mysoline® 50 mg, after an overnight fast of at least 10 hours, followed by a 14 day washout period. On the morning of Day 15 subjects received one tablet of the test formulation, Primidone 50 mg, after an overnight fast of at least 10 hours.
|
|---|---|---|
|
First Intervention
STARTED
|
11
|
11
|
|
First Intervention
COMPLETED
|
11
|
11
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout Period of 14 Days
STARTED
|
11
|
11
|
|
Washout Period of 14 Days
COMPLETED
|
10
|
11
|
|
Washout Period of 14 Days
NOT COMPLETED
|
1
|
0
|
|
Second Intervention
STARTED
|
10
|
11
|
|
Second Intervention
COMPLETED
|
10
|
11
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Primidone 50 mg Tablets Then Mysoline® 50 mg Tablets
On the morning of Day 1 subjects received one tablet of the test formulation, primidone 50 mg, after an overnight fast of at least 10 hours, followed by a 14 day washout period. On the morning of Day 15 subjects received one tablet of the reference formulation, Mysoline® 50 mg, after an overnight fast of at least 10 hours.
|
Mysoline® 50 mg Tablets Then Primidone 50 mg Tablets
On the morning of Day 1 subjects received one tablet of the reference formulation, Mysoline® 50 mg, after an overnight fast of at least 10 hours, followed by a 14 day washout period. On the morning of Day 15 subjects received one tablet of the test formulation, Primidone 50 mg, after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Washout Period of 14 Days
Adverse Event
|
1
|
0
|
Baseline Characteristics
Fasted Bioequivalence Study of Primidone Tablets and Mysoline Tablets
Baseline characteristics by cohort
| Measure |
Primidone 50 mg Tablets and Mysoline® 50 mg Tablets
n=22 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 15, each subject received one tablet of either primidone 50 mg or Mysoline® 50 mg following an overnight fast of at least 10 hours.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age Continuous
|
31.76 years
STANDARD_DEVIATION 12.10 • n=99 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours after drug administration.Population: Plasma concentration data for 21 of 22 participants were used in the statistical analysis. One subject dropped from the study before Period II dosing due to an adverse event.
The maximum or peak concentration that the drug reaches in the plasma.
Outcome measures
| Measure |
Primidone 50 mg Tablets
n=21 Participants
Each subject received one tablet of primidone 50 mg after an overnight fast of at least 10 hours.
|
Mysoline® 50 mg Tablets
n=21 Participants
Each subject received one tablet of Mysoline® 50 mg after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
1,165.92 ng/mL
Standard Deviation 216.64
|
1,202.28 ng/mL
Standard Deviation 273.28
|
PRIMARY outcome
Timeframe: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours after drug administration.Population: Plasma concentration data for 21 of 22 participants were used in the statistical analysis. One subject dropped from the study before Period II dosing due to an adverse event.
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 |
Primidone 50 mg Tablets
n=21 Participants
Each subject received one tablet of primidone 50 mg after an overnight fast of at least 10 hours.
|
Mysoline® 50 mg Tablets
n=21 Participants
Each subject received one tablet of Mysoline® 50 mg after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
|
27,893.57 ng-hr/mL
Standard Deviation 3,709.32
|
27,519.67 ng-hr/mL
Standard Deviation 3,606.54
|
PRIMARY outcome
Timeframe: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours after drug administration.Population: Plasma concentration data for 21 of 22 participants were used in the statistical analysis. One subject dropped from the study before Period II dosing due to an adverse event.
The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.
Outcome measures
| Measure |
Primidone 50 mg Tablets
n=21 Participants
Each subject received one tablet of primidone 50 mg after an overnight fast of at least 10 hours.
|
Mysoline® 50 mg Tablets
n=21 Participants
Each subject received one tablet of Mysoline® 50 mg after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]
|
31,162.82 ng-hr/mL
Standard Deviation 3,922.58
|
30,583.92 ng-hr/mL
Standard Deviation 3,786.58
|
Adverse Events
Primidone 50 mg Tablets
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Mysoline® 50 mg Tablets
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Primidone 50 mg Tablets
n=22 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 15, each subject received one tablet of either primidone 50 mg or Mysoline® 50 mg following an overnight fast.
|
Mysoline® 50 mg Tablets
n=21 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 15, each subject received one tablet of either primidone 50 mg or Mysoline® 50 mg following an overnight fast.
|
|---|---|---|
|
Nervous system disorders
Confusion
|
4.5%
1/22 • Number of events 1
|
4.8%
1/21 • Number of events 1
|
|
General disorders
Cramping
|
4.5%
1/22 • Number of events 1
|
0.00%
0/21
|
|
Eye disorders
Diplopia
|
9.1%
2/22 • Number of events 2
|
0.00%
0/21
|
|
Nervous system disorders
Lightheadedness
|
4.5%
1/22 • Number of events 1
|
9.5%
2/21 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/22
|
4.8%
1/21 • Number of events 1
|
|
General disorders
Near syncopal episode
|
0.00%
0/22
|
4.8%
1/21 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
4.5%
1/22 • Number of events 1
|
0.00%
0/21
|
|
Infections and infestations
Upper Respiratory Infection
|
4.5%
1/22 • Number of events 1
|
0.00%
0/21
|
|
General disorders
Weakness
|
0.00%
0/22
|
4.8%
1/21 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60