Trial Outcomes & Findings for A Study to Assess if Epanutin Infatabs 50 mg From Germany Are Similar to Dilantin Infatabs 50 mg From Australia (NCT NCT01355068)
NCT ID: NCT01355068
Last Updated: 2021-01-28
Results Overview
Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).
COMPLETED
PHASE1
26 participants
0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, and 72 hours (hrs) post-dose
2021-01-28
Participant Flow
Participant milestones
| Measure |
Epanutin Infatabs 50 mg First, Then Dilantin Infatabs 50 mg
Single oral dose of Epanutin (phenytoin) infatabs 50 milligram (mg) chewable tablet in first intervention period; and single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet in second intervention period. A washout period of at least 7 days was maintained between each period.
|
Dilantin Infatabs 50 mg First, Then Epanutin Infatabs 50 mg
Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet in first intervention period; and single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet in second intervention period. A washout period of at least 7 days was maintained between each period.
|
|---|---|---|
|
First Intervention Period
STARTED
|
13
|
13
|
|
First Intervention Period
COMPLETED
|
13
|
11
|
|
First Intervention Period
NOT COMPLETED
|
0
|
2
|
|
Washout Period (at Least 7 Days)
STARTED
|
13
|
11
|
|
Washout Period (at Least 7 Days)
COMPLETED
|
13
|
11
|
|
Washout Period (at Least 7 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention Period
STARTED
|
13
|
11
|
|
Second Intervention Period
COMPLETED
|
13
|
11
|
|
Second Intervention Period
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Epanutin Infatabs 50 mg First, Then Dilantin Infatabs 50 mg
Single oral dose of Epanutin (phenytoin) infatabs 50 milligram (mg) chewable tablet in first intervention period; and single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet in second intervention period. A washout period of at least 7 days was maintained between each period.
|
Dilantin Infatabs 50 mg First, Then Epanutin Infatabs 50 mg
Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet in first intervention period; and single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet in second intervention period. A washout period of at least 7 days was maintained between each period.
|
|---|---|---|
|
First Intervention Period
Adverse Event
|
0
|
1
|
|
First Intervention Period
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
A Study to Assess if Epanutin Infatabs 50 mg From Germany Are Similar to Dilantin Infatabs 50 mg From Australia
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=26 Participants
Includes participants randomized to receive Epanutin (phenytoin) infatabs 50 mg first and Dilantin (phenytoin) infatabs 50 mg first.
|
|---|---|
|
Age, Continuous
|
31.8 years
STANDARD_DEVIATION 8.3 • n=39 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, and 72 hours (hrs) post-dosePopulation: Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).
Outcome measures
| Measure |
Epanutin Infatabs 50 mg
n=24 Participants
Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
|
Dilantin Infatabs 50 mg
n=26 Participants
Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
|
|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
|
21380.0 ng*hr/mL
Standard Deviation 6043.0
|
21370.0 ng*hr/mL
Standard Deviation 5571.2
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dosePopulation: PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Outcome measures
| Measure |
Epanutin Infatabs 50 mg
n=24 Participants
Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
|
Dilantin Infatabs 50 mg
n=26 Participants
Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
952.10 ng/mL
Standard Deviation 229.25
|
976.50 ng/mL
Standard Deviation 214.78
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dosePopulation: PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).
Outcome measures
| Measure |
Epanutin Infatabs 50 mg
n=23 Participants
Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
|
Dilantin Infatabs 50 mg
n=25 Participants
Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
|
|---|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0-∞])
|
21730.0 ng*hr/mL
Standard Deviation 6345.9
|
21740.0 ng*hr/mL
Standard Deviation 5816.7
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dosePopulation: PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
AUC%extrap is the percentage of AUC \[0-∞\] obtained by forward extrapolation. It is calculated as (AUC \[0-∞\] minus AUClast)\*100/ AUC \[0-∞\], where AUC \[0-∞\] = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-∞) and AUClast is area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration.
Outcome measures
| Measure |
Epanutin Infatabs 50 mg
n=24 Participants
Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
|
Dilantin Infatabs 50 mg
n=26 Participants
Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
|
|---|---|---|
|
Extrapolated Area Under the Curve (AUC Percent [%] Extrap)
|
3.321 Percent AUC
Standard Deviation 4.884
|
3.198 Percent AUC
Standard Deviation 4.805
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dosePopulation: PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Outcome measures
| Measure |
Epanutin Infatabs 50 mg
n=23 Participants
Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
|
Dilantin Infatabs 50 mg
n=26 Participants
Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
|
|---|---|---|
|
Plasma Decay Half Life (t1/2)
|
14.380 hr
Standard Deviation 3.247
|
14.970 hr
Standard Deviation 4.777
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dosePopulation: PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Outcome measures
| Measure |
Epanutin Infatabs 50 mg
n=24 Participants
Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
|
Dilantin Infatabs 50 mg
n=26 Participants
Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
|
|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
|
3.51 hr
Interval 1.0 to 5.0
|
4.00 hr
Interval 1.0 to 6.0
|
Adverse Events
Epanutin Infatabs 50 mg
Dilantin Infatabs 50 mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Epanutin Infatabs 50 mg
n=24 participants at risk
Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
|
Dilantin Infatabs 50 mg
n=26 participants at risk
Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
4.2%
1/24
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.8%
1/26
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
4.2%
1/24
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/26
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
8.3%
2/24
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/26
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/24
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.8%
1/26
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER