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| ID | Type | Description | Link |
|---|---|---|---|
| HHSF223201400188C | Other Grant/Funding Number | USFDA |
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| Name | Class |
|---|---|
| University of Maryland, Baltimore | OTHER |
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Some epilepsy patients are described as GB when they have worsened seizures or side effects related to switching between brand name and generic, or between generic antiepileptic drug (AED) products. In concert with Aim 1 (protocol BEEP2a), this study will uncover possible reasons for patient problems with the drug switching. Factors that will be studied in GB epilepsy patients include physiologic, psychological, and genetic factors, including in this protocol whether brand and generic AEDs are pharmacokinetically similar in GB individuals.
This pilot study is exploratory research to characterize the "generic brittle" (GB) patient and to identify major causes for generic brittleness in epilepsy patients who are sensitive to antiepileptic drug (AED) formulation changes.
The primary aim of this BEEP2b study is to perform individual pharmacokinetic (PK) similarity testing of brand and generic AEDs in "probably GB" patients (N=12),who were selected on the basis of having GB-defining factors from the BEEP2a study, in order to confirm whether these factors are predictive of a generic brittle response to product switching. The study design involves a randomized, double-blind, multiple-dose, complete four-way replicate crossover design in which one brand and one generic will be compared in each patient from the patient's own AED regimen. Associated adverse events (i.e. seizures and side effects) will also be assessed. Bioequivalence (BE) will not be assessed. Rather, about nine AEDs are expected to be collectively evaluated. Generic brittleness anticipates that, for individual subjects, brand and generic may be the same or different, depending upon the underlying basis for generic brittleness. This exploratory research is focused on understanding individual patient attributes that contribute to GB, and is not focused on either product development or comparison of specific products.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Active Comparator | This is a crossover study with 4 treatment periods consisting of 2 Test periods(generic drug) and 2 Reference periods (brand name drug). Each treatment period lasts about 2 weeks, and patients will be randomized into one of the two sequences. All drugs are administered orally, and dosage will depend on a patient. |
|
| Sequence 2 | Active Comparator | This is a crossover study with 4 treatment periods consisting of 2 Test periods(generic drug) and 2 Reference periods (brand name drug). Each treatment period lasts about 2 weeks, and patients will be randomized into one of the two sequences. All drugs are administered orally, and dosage will depend on a patient. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxcarbazepine (brand name vs generic drugs) | Drug | This is a cross-over replicate study with 2 sequences (arms) comparing brand name and generic anti-epileptic drugs. Subjects will take a brand name and a generic drug of the same intervention. While there are only 2 sequences, there are 8 possible drugs for this study, and a study patient will only take 1 out of 8 study drugs. Only pharmacists will know which sequence each patient is assigned to. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean AUC0-last_ss (Test vs. Reference) | Average AUC (area under the drug plasma curve. | For all study drugs, time points are: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, and 6 hr postdose. For twice-a-day regimen, additional points are:8, 10, and 12 hr postdose. For once-a-day drugs, additional times are:8, 10, 12, 16, and 24 hr postdose. |
| Mean Cmax_ss (Test vs. Reference) | Average maximum drug plasma concentration; | For all study drugs, time points are: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, and 6 hr postdose. For twice-a-day regimen, additional points are:8, 10, and 12 hr postdose. For once-a-day drugs, additional times are:8, 10, 12, 16, and 24 hr postdose. |
| Mean Cmin_ss (Test vs. Reference) | Average minimum drug plasma concentration (Cmin); | For all study drugs, time points are: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, and 6 hr postdose. For twice-a-day regimen, additional points are:8, 10, and 12 hr postdose. For once-a-day drugs, additional times are:8, 10, 12, 16, and 24 hr postdose. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events | summed for each anti-epileptic drug from when taking brand and generic. | Through the approximately 2 week period when the treatment is given. |
| Number of Seizures Reported |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James E Polli, Ph.D | University of Maryland School of Pharmacy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland, Baltimore | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17346246 | Background | Andermann F, Duh MS, Gosselin A, Paradis PE. Compulsory generic switching of antiepileptic drugs: high switchback rates to branded compounds compared with other drug classes. Epilepsia. 2007 Mar;48(3):464-9. doi: 10.1111/j.1528-1167.2007.01007.x. | |
| 18616554 | Background | Zachry WM 3rd, Doan QD, Clewell JD, Smith BJ. Case-control analysis of ambulance, emergency room, or inpatient hospital events for epilepsy and antiepileptic drug formulation changes. Epilepsia. 2009 Mar;50(3):493-500. doi: 10.1111/j.1528-1167.2008.01703.x. Epub 2008 Jun 26. |
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There is no plan to make individual participant data available.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1/Topiramate | Subjects received Topiramate in the sequence order 1 (TRRT). Test-Reference-Reference-Test Reference: Brand Test: Generic |
| FG001 | Sequence 2/Topiramate |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 13, 2018 |
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|
| Divalproex Sodium (brand name vs generic drugs) | Drug | This is a cross-over replicate study with 2 sequences (arms) comparing brand name and generic anti-epileptic drugs. Subjects will take a brand name and a generic drug of the same intervention. While there are only 2 sequences, there are 8 possible drugs for this study, and a study patient will only take 1 out of 8 study drugs. Only pharmacists will know which sequence each patient is assigned to. |
|
| Carbamazepine (brand name vs generic drugs) | Drug | This is a cross-over replicate study with 2 sequences (arms) comparing brand name and generic anti-epileptic drugs. Subjects will take a brand name and a generic drug of the same intervention. While there are only 2 sequences, there are 8 possible drugs for this study, and a study patient will only take 1 out of 8 study drugs. Only pharmacists will know which sequence each patient is assigned to. |
|
| Lamotrigine (brand name vs generic drugs) | Drug | This is a cross-over replicate study with 2 sequences (arms) comparing brand name and generic anti-epileptic drugs. Subjects will take a brand name and a generic drug of the same intervention. While there are only 2 sequences, there are 8 possible drugs for this study, and a study patient will only take 1 out of 8 study drugs. Only pharmacists will know which sequence each patient is assigned to. |
|
| levetiracetam (brand name vs generic drugs) | Drug | This is a cross-over replicate study with 2 sequences (arms) comparing brand name and generic anti-epileptic drugs. Subjects will take a brand name and a generic drug of the same intervention. While there are only 2 sequences, there are 8 possible drugs for this study, and a study patient will only take 1 out of 8 study drugs. Only pharmacists will know which sequence each patient is assigned to. |
|
| Topiramate (brand name vs generic drugs) | Drug | This is a cross-over replicate study with 2 sequences (arms) comparing brand name and generic anti-epileptic drugs. Subjects will take a brand name and a generic drug of the same intervention. While there are only 2 sequences, there are 8 possible drugs for this study, and a study patient will only take 1 out of 8 study drugs. Only pharmacists will know which sequence each patient is assigned to. |
|
| Zonisamide (brand name vs generic drugs) | Drug | This is a cross-over replicate study with 2 sequences (arms) comparing brand name and generic anti-epileptic drugs. Subjects will take a brand name and a generic drug of the same intervention. While there are only 2 sequences, there are 8 possible drugs for this study, and a study patient will only take 1 out of 8 study drugs. Only pharmacists will know which sequence each patient is assigned to. |
|
| Phenytoin sodium (brand name vs generic drugs) | Drug | This is a cross-over replicate study with 2 sequences (arms) comparing brand name and generic anti-epileptic drugs. Subjects will take a brand name and a generic drug of the same intervention. While there are only 2 sequences, there are 8 possible drugs for this study, and a study patient will only take 1 out of 8 study drugs. Only pharmacists will know which sequence each patient is assigned to. |
|
Number of seizures reported in all groups
| Through the approximately 2 week period when the treatment is given. |
| 19558250 | Background | Rascati KL, Richards KM, Johnsrud MT, Mann TA. Effects of antiepileptic drug substitutions on epileptic events requiring acute care. Pharmacotherapy. 2009 Jul;29(7):769-74. doi: 10.1592/phco.29.7.769. |
| 21521860 | Background | Fitzgerald CL, Jacobson MP. Generic substitution of levetiracetam resulting in increased incidence of breakthrough seizures. Ann Pharmacother. 2011 May;45(5):e27. doi: 10.1345/aph.1P765. Epub 2011 Apr 26. |
| 20384761 | Background | Bialer M, Midha KK. Generic products of antiepileptic drugs: a perspective on bioequivalence and interchangeability. Epilepsia. 2010 Jun;51(6):941-50. doi: 10.1111/j.1528-1167.2010.02573.x. Epub 2010 Apr 8. |
| 17438213 | Background | Liow K, Barkley GL, Pollard JR, Harden CL, Bazil CW; American Academy of Neurology. Position statement on the coverage of anticonvulsant drugs for the treatment of epilepsy. Neurology. 2007 Apr 17;68(16):1249-50. doi: 10.1212/01.wnl.0000259400.30539.cc. No abstract available. |
| 22477799 | Background | Shaw SJ, Hartman AL. The Controversy over Generic Antiepileptic Drugs. J Pediatr Pharmacol Ther. 2010 Apr;15(2):81-93. |
| 18768168 | Background | McAuley JW, Chen AY, Elliott JO, Shneker BF. An assessment of patient and pharmacist knowledge of and attitudes toward reporting adverse drug events due to formulation switching in patients with epilepsy. Epilepsy Behav. 2009 Jan;14(1):113-7. doi: 10.1016/j.yebeh.2008.08.009. Epub 2008 Sep 26. |
| 26201987 | Background | Ting TY, Jiang W, Lionberger R, Wong J, Jones JW, Kane MA, Krumholz A, Temple R, Polli JE. Generic lamotrigine versus brand-name Lamictal bioequivalence in patients with epilepsy: A field test of the FDA bioequivalence standard. Epilepsia. 2015 Sep;56(9):1415-24. doi: 10.1111/epi.13095. Epub 2015 Jul 23. |
| 10189261 | Background | Stevens RE, Limsakun T, Evans G, Mason DH Jr. Controlled, multidose, pharmacokinetic evaluation of two extended-release carbamazepine formulations (Carbatrol and Tegretol-XR). J Pharm Sci. 1998 Dec;87(12):1531-4. doi: 10.1021/js980203+. |
| 19264451 | Background | Rouits E, Burton I, Guenole E, Troenaru MM, Stockis A, Sargentini-Maier ML. Pharmacokinetics of levetiracetam XR 500mg tablets. Epilepsy Res. 2009 Apr;84(2-3):224-31. doi: 10.1016/j.eplepsyres.2009.02.001. Epub 2009 Mar 4. |
| 23758485 | Background | Elger C, Bialer M, Falcao A, Vaz-da-Silva M, Nunes T, Almeida L, Soares-da-Silva P. Pharmacokinetics and tolerability of eslicarbazepine acetate and oxcarbazepine at steady state in healthy volunteers. Epilepsia. 2013 Aug;54(8):1453-61. doi: 10.1111/epi.12242. Epub 2013 Jun 12. |
| 22162508 | Background | Cawello W, Bonn R. No pharmacokinetic interaction between lacosamide and valproic acid in healthy volunteers. J Clin Pharmacol. 2012 Nov;52(11):1739-48. doi: 10.1177/0091270011426875. Epub 2011 Dec 8. |
Subjects received Topiramate in the sequence order 2 (RTTR).
Reference-Test-Test-Reference
Reference: Brand Test: Generic
| FG002 | Sequence 1/Lamotrigine | Subjects received Lamotrigine in the sequence order 1 (TRRT). Test-Reference-Reference-Test Reference: Brand Test: Generic |
| FG003 | Sequence 2/Lamotrigine | Subjects received Lamotrigine in the sequence order 2 (RTTR). Reference-Test-Test-Reference Reference: Brand Test: Generic |
| FG004 | Sequence 1/Levetiracetam IR | Subjects received Levetiracetam IR in the sequence order 1 (TRRT). Test-Reference-Reference-Test Reference: Brand Test: Generic |
| FG005 | Sequence 2/Levetiracetam IR | Subjects received Levetiracetam IR in the sequence order 2 (RTTR). Reference-Test-Test-Reference Reference: Brand Test: Generic |
| FG006 | Sequence 1/Carbamazepine ER Tablet | Subjects received Carbamazepine ER tablet in the sequence order 1 (TRRT). Test-Reference-Reference-Test Reference: Brand Test: Generic |
| FG007 | Sequence 2/Carbamazepine ER Tablet | Subjects received Carbamazepine ER tablet in the sequence order 2 (RTTR). Reference-Test-Test-Reference Reference: Brand Test: Generic |
| FG008 | Sequence 1/Carbamazepine ER Capsule | Subjects received Carbamazepine ER capsule in the sequence order 1 (TRRT). Test-Reference-Reference-Test Reference: Brand Test: Generic |
| FG009 | Sequence 2/Carbamazepine ER Capsule | Subjects received Carbamazepine ER capsule in the sequence order 2 (RTTR). Reference-Test-Test-Reference Reference: Brand Test: Generic |
| FG010 | Sequence 1/Zonisamide | Subjects received Zonisamide in the sequence order 1 (TRRT). Test-Reference-Reference-Test Reference: Brand Test: Generic |
| FG011 | Sequence 2/Zonisamide | Subjects received Zonisamide in the sequence order 2 (RTTR). Reference-Test-Test-Reference Reference: Brand Test: Generic |
| FG012 | Sequence 1/Levetiracetam ER | Subjects received Levetiracetam in the sequence order 1 (TRRT). Test-Reference-Reference-Test Reference: Brand Test: Generic |
| FG013 | Sequence 2/Levetiracetam ER | Subjects received Levetiracetam ER in the sequence order 2 (RTTR). Reference-Test-Test-Reference Reference: Brand Test: Generic |
| FG014 | Sequence 1/Valproic Acid | Subjects received Valproic acid in the sequence order 1 (TRRT). Test-Reference-Reference-Test Reference: Brand Test: Generic |
| FG015 | Sequence 2/Valproic Acid | Subjects received Valproic acid in the sequence order 2 (RTTR). Reference-Test-Test-Reference Reference: Brand Test: Generic |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All subjects who received a study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Topiramate Tablet Group | All subjects who received the Topiramate Tablet. |
| BG001 | Lamotrigine IR Tablet Group | All subjects who received the Lamotrigine IR Tablet. |
| BG002 | Lamotrigine ER Tablet Group | All subjects who received the Lamotrigine ER Tablet. |
| BG003 | Levetiracetam IR Tablet Group | All subjects who received the Levetiracetam IR Tablet. |
| BG004 | Levetiracetam ER Tablet Group | All subjects who received the Levetiracetam ER Tablet. |
| BG005 | Carbamazepine ER Capsule | All subjects who received the Carbamazepine ER Capsule. |
| BG006 | Carbamazepine ER Tablet | All subjects who received the Carbamazepine ER Tablet. |
| BG007 | Zonisamide Capsule Group | All subjects who received the Zonisamide Capsule. |
| BG008 | Valproic Acid ER Tablet Group | All subjects who received the Valproic Acid ER Tablet. |
| BG009 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean AUC0-last_ss (Test vs. Reference) | Average AUC (area under the drug plasma curve. | Posted | Mean | Standard Deviation | micro/mL/hr | For all study drugs, time points are: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, and 6 hr postdose. For twice-a-day regimen, additional points are:8, 10, and 12 hr postdose. For once-a-day drugs, additional times are:8, 10, 12, 16, and 24 hr postdose. |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Primary | Mean Cmax_ss (Test vs. Reference) | Average maximum drug plasma concentration; | Posted | Mean | Standard Deviation | microg/mL | For all study drugs, time points are: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, and 6 hr postdose. For twice-a-day regimen, additional points are:8, 10, and 12 hr postdose. For once-a-day drugs, additional times are:8, 10, 12, 16, and 24 hr postdose. |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Mean Cmin_ss (Test vs. Reference) | Average minimum drug plasma concentration (Cmin); | Posted | Mean | Standard Deviation | microg/mL | For all study drugs, time points are: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, and 6 hr postdose. For twice-a-day regimen, additional points are:8, 10, and 12 hr postdose. For once-a-day drugs, additional times are:8, 10, 12, 16, and 24 hr postdose. |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Adverse Events | summed for each anti-epileptic drug from when taking brand and generic. | Posted | Number | events | Through the approximately 2 week period when the treatment is given. |
| |||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Seizures Reported | Number of seizures reported in all groups | Posted | Number | Number of Seizures | Through the approximately 2 week period when the treatment is given. |
|
Approximately 16 weeks per subject
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Topiramate | Subjects who received Topiramate for Sequence 1 and 2. | 0 | 5 | 0 | 5 | 5 | 5 |
| EG001 | Lamotrigine ER | Subjects who received Lamotrigine ER for Sequence 1 and 2. | 0 | 4 | 0 | 3 | 4 | 4 |
| EG002 | Levetiracetam IR | Subjects who received Levetiracetam IR for Sequence 1 and 2. | 0 | 3 | 0 | 3 | 2 | 3 |
| EG003 | Levetiracetam ER | Subjects who received Levetiracetam ER for Sequence 1 and 2. | 0 | 2 | 0 | 2 | 2 | 2 |
| EG004 | Carbamazepine ER Capsule | Subjects who received Carbamazepine ER Capsule for Sequence 1 and 2. | 0 | 1 | 0 | 1 | 2 | 3 |
| EG005 | Zonisamide | Subjects who received Zonisamide for Sequence 1 and 2. | 0 | 1 | 0 | 1 | 1 | 1 |
| EG006 | Carbamazepine ER Tablet | Subjects who received Carbamazepine ER Tablet for Sequence 1 and 2. | 0 | 3 | 0 | 1 | 1 | 1 |
| EG007 | Valproic Acid | Subjects who received Valproic acid for Sequence 1 and 2. | 0 | 2 | 0 | 2 | 1 | 2 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening of aphrasia | Nervous system disorders | Non-systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Somnolence | Nervous system disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Psychosis | Psychiatric disorders | Non-systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Irritability | Psychiatric disorders | Non-systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Mood swing | Psychiatric disorders | Non-systematic Assessment |
| ||
| Tremor | Nervous system disorders | Non-systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
| ||
| Shoulder/arm pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
The research was exploratory. The study was not a bioequivalence study.
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. James Polli | University of Maryland, School of Pharmacy | 410-706-8292 | jpolli@rx.umaryland.edu |
| Jan 21, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000078330 | Oxcarbazepine |
| D014635 | Valproic Acid |
| D002220 | Carbamazepine |
| D000077213 | Lamotrigine |
| D000077287 | Levetiracetam |
| D000077236 | Topiramate |
| D000078305 | Zonisamide |
| D010672 | Phenytoin |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D014227 | Triazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D000081 | Acetamides |
| D000577 | Amides |
| D000085 | Acetates |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D005632 | Fructose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D007661 | Ketoses |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006827 | Hydantoins |
| D048289 | Imidazolidines |
| D007093 | Imidazoles |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Reference Product |
|
Subjects who received Carbamazepine ER Capsule for Sequence 1 and 2.
| OG005 | Carbamazepine ER Tablet | Subjects who received Carbamazepine ER Tablet for Sequence 1 and 2. |
| OG006 | Zonisamide Capsule | Subjects who received Zonisamide for Sequence 1 and 2. |
|
|
Subjects who received Carbamazepine ER Capsule for Sequence 1 and 2.
| OG005 | Carbamazepine ER Tablet | Subjects who received Carbamazepine ER Tablet for Sequence 1 and 2. |
| OG006 | Zonisamide Capsule | Subjects who received Zonisamide for Sequence 1 and 2. |
|
|
| OG005 |
| Zonisamide |
Subjects who received Zonisamide for Sequence 1 and 2. |
| OG006 | Carbamazepine ER Tablet | Subjects who received Carbamazepine ER Tablet for Sequence 1 and 2. |
| OG007 | Valproic Acid | Subjects who received Valproic acid for Sequence 1 and 2. |
|
|
| OG005 |
| Carbamazepine ER Capsule |
All subjects who received the Carbamazepine ER Capsule. |
| OG006 | Carbamazepine ER Tablet | All subjects who received the Carbamazepine ER Tablet. |
| OG007 | Zonisamide Capsule Group | All subjects who received the Zonisamide Capsule. |
| OG008 | Valproic Acid ER Tablet Group | All subjects who received the Valproic Acid ER Tablet. |
|
|