CTRI/2020/11/029355
Completed
未知
A randomized, open label, multiple-dose, multi-centre, two-treatment, two-period, two-sequence, two-way crossover, steady-state pharmacokinetic bioequivalence study of Vigabatrin Tablets 500 mg manufactured by Amneal Pharmaceuticals LLC with SABRIL (vigabatrin) tablets 500 mg Manufactured by: Patheon Cincinnati, OH 45237, U.S.A. For: Lundbeck Deerfield, IL 60015, U.S.A. in refractory complex partial-seizure adult patients who are already on established Vigabatrin adjunctive therapy under fasting conditions - NA
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: G402- Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures
- Sponsor
- Amneal Pharmaceuticals LLC
- Enrollment
- 36
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patient or LAR willing and able to provide voluntary informed consent
- •2\. Male or female aged 18 to 55 years (both inclusive) at the time of consent.
- •3\. Adult patients with refractory complex partial\-seizure who are already on established vigabatrin adjunctive therapy with a dose of 500 mg twice daily for at least one month prior to Day 0 of the study.
- •4\. Acceptable hematology status:
- •a. Hemoglobin greater than or equal to 11 g per dL
- •b. Absolute neutrophil count (ANC) greater than or equal to 1500 cells per microliter
- •c. Platelet count greater than or equal to 150,000 cells per microliter
- •5\. Acceptable liver function:
- •a. Alanine aminotransferase less than or equal to 2\.5 X ULN
- •b. Aspartate aminotransferase less than or equal to 2\.5 X ULN
Exclusion Criteria
- •The subjects will be excluded from the study based on the following criteria:
- •1\. History of hypersensitivity to Vigabatrin or to any of the excipients as judged by investigator.
- •2\. Patients who require dose\-change or anticipated to have change in dose during the treatment period.
- •3\. Patient is taking other drugs associated with serious adverse ophthalmic effects, such as retinopathy.
- •4\. History of systemic illness like chronic hepatic, renal, pulmonary, cardiac disease or any other significant illness or any other significant abnormal laboratory results at the time of screening which may increase the risk to the patient, as judged by the investigator
- •5\. Patient with abnormal vision assessment test at the time of screening.
- •6\. Patients with positive HIV antibody, HBsAg or HCV antibody.
- •7\. Patients who pose a significant risk of a suicide attempt based on history within the past 3 months prior to screening, investigators judgment or have answered yes on the questions 4 or 5 at Screening on Columbia Suicide Severity Rating Scale (C\-SSRS) (Appendix B)
- •8\. Patient with diabetic retinopathy, glaucoma or other retinal diseases.
- •9\. Patients with a decline in vision compared to baseline within 30 days prior to study enrollment
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 1
Bioequivalence study comparing felbamate tablets USP 600 mg of Emcure Pharmaceuticals Ltd., India to the Reference Listed Drug (RLD), Felbatol® (felbamate) 600 mg tablets manufactured by MEDA Pharmaceuticals Inc, USA in adult male and nonpregnant female epilepsy patients.Health Condition 1: null- Refractory EpilepsyCTRI/2015/08/006138Emcure Pharmaceuticals Ltd28
Completed
Not Applicable
An open-label, multiple dose, randomized, two-way crossover study to evaluate the effects of BGG492 on the pharmacokinetics and pharmacodynamics of a monophasic oral contraceptive in healthy female volunteersEpilepsieEpilepsiafalling diseaseNL-OMON34415ovartis24
Completed
Not Applicable
Azathioprine Bioequivalence study in Rheumatoid ArthritisHealth Condition 1: null- Rheumatoid ArthritisCTRI/2010/091/000070Orion Pharma42
Unknown
Not Applicable
Steady - State Bioequivalence Study of Felbamate Oral suspension 600 mg/5 mL (Fasting)CTRI/2017/05/008506Getz Pharma Research Pvt Ltd38
Completed
Not Applicable
Steady - State Bioequivalence Study of Felbamate Tablets 600 mg (Fasting)Health Condition 1: null- adult male and non-pregnant female epilepsy patients already established (run-in) on Felbamate as an monotherapy/adjunctive therapy under fasting conditionCTRI/2015/06/005925Getz Pharma Research Pvt Ltd38