| CTRI Number |
CTRI/2009/091/000708 [Registered on: 05/10/2009] |
| Last Modified On: |
11/08/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
Type of Study
Modification(s)
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| Study Design |
Randomized, Crossover Trial |
Public Title of Study
Modification(s)
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A clinical trial to evaluate the blood levels of Felbamate after administration of Amneal Pharmaceuticals felbamate suspension (test) compared to the Reference Drug Felbatol® suspension (felbamate) in epilepsy patients |
Scientific Title of Study
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A randomized, open label, multi-dose, two treatment, two-way crossover, steady state, bioequivalence study comparing Amneal Pharmaceuticals Felbamate 600 mg/5 ml oral suspension to the Reference Listed Drug (RLD), Felbatol® (felbamate) 600 mg/5 ml oral suspension Manufactured by MEDA Pharmaceuticals (formerly Medpointe) in adult male and non-pregnant female epilepsy patients under fasting condition |
| Trial Acronym |
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Secondary IDs if Any
Modification(s)
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| Secondary ID |
Identifier |
| MA-CT-09-005 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
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| Name |
Dr Shalini Agarwal |
| Designation |
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| Affiliation |
Manipal Acunova |
| Address |
Manipal Acunova Ltd., Mobius Towers, SJR-I-Park
EPIP, White Field
Bangalore
KARNATAKA
560066
India |
| Phone |
91-80-66915776 |
| Fax |
91-80-66915719 |
| Email |
shalini.agarwal@ecronacunova.com |
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Details of Contact Person
Public Query
Modification(s)
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| Name |
Vinod M |
| Designation |
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| Affiliation |
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| Address |
Manipal Acunova Ltd., Mobius Towers, SJR-I-Park
EPIP, White Field
Bangalore
KARNATAKA
560066
India |
| Phone |
91-80-66915754 |
| Fax |
91-80-66915719 |
| Email |
vinod.m@ecronacunova.com |
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Source of Monetary or Material Support
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| Amneal Pharmaceuticals of NY
85 Adams Avenue, Hauppauge
NY 11788
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Primary Sponsor
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| Name |
Amneal Pharmaceuticals |
| Address |
NY85 Adams Avenue, HauppaugeNY 11788 |
| Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr R Umashankar |
Padmashree Diagnostics |
17th Cross , MC Layout,Chord Road, Vijayanagar-560040
Bangalore
KARNATAKA |
91-80-23354249
91-80-23354249
umaneuro@yahoo.co.in |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinicom Ethics Committee for Padmashree Diagnostics |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
Modification(s)
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| Health Type |
Condition |
| Patients |
Refractory Epilepsy , |
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Intervention / Comparator Agent
Modification(s)
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| Type |
Name |
Details |
| Intervention |
Felbamate 600 mg/5 ml oral suspension |
Oral doses of felbamate suspension (600 mg or multiples of 600 mg) given three times daily amounting to a total of 1800 to 4800 mg/day for a period of 14 days |
| Comparator Agent |
Felbatol® 600 mg/5 ml oral suspension |
Oral doses of Felbatol® suspension (600 mg or multiples of 600 mg) given three times daily amounting to a total of 1800 to 4800 mg/day for a period of 14 days |
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Inclusion Criteria
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| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female patients, 18 years of age or older, diagnosed with refractory epilepsy, who do not respond adequately to alternative treatment.
2. Patients should be on a stable dose of Felbamate (1800 to 4800 mg/day given in divided doses three or four times per day) for at least two weeks prior to randomization
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| ExclusionCriteria |
| Details |
Patients with concurrent psychiatric diagnosis, hematology counts below LLN, history of aplastic anemia or bone marrow suppression, serum transaminases 2x ULN or history or evidence of hepatic dysfunction.
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Method of Generating Random Sequence
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Permuted block randomization, fixed |
Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
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Open Label |
Primary Outcome
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| Outcome |
TimePoints |
AUCss, Cmax and Cmin
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Repeated post dose blood sampling till 8 hours after dosing |
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Secondary Outcome
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| Outcome |
TimePoints |
| Tmax and % Fluctuation |
Repeated post dose blood sampling till 8 hours after dosing |
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Target Sample Size
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Total Sample Size="28"
Sample Size from India="28"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
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Phase 1 |
Date of First Enrollment (India)
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01/12/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
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Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
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Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
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None |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
Modification(s)
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This is a randomized, open label, multi-dose, two treatment, two-way crossover, steady state, bioequivalence study to compare the bioavailability of Amneal Pharmaceuticals Felbamate 600/5 ml suspension (test) to the Reference Listed Drug Felbatol® (felbamate) 600/5 ml mg suspension in patients with epilepsy under fasting condition. 28 patients with refractory epilepsy, controlled and maintained on 1800 to 4800 mg/day doses of felbamate for at least two weeks prior to randomization will be eligible to enter the 14 day study period with no washout between the two periods. Repeated post-dose blood sampling will be done for evaluating the pharmacokinetic parameters in both the periods. The primary outcome measure is to establish bioequivalence of two fomulations on the basis of geometric means and 90% confidence intervals of the AUCss and Cmax ratio (test/reference). |