| CTRI Number |
CTRI/2009/091/000706 [Registered on: 16/09/2009] |
| Last Modified On: |
11/01/2017 |
| 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 tablets (test) compared to the Reference Drug Felbatol® tablets (felbamate) in epilepsy patients |
Scientific Title of Study
Modification(s)
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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 tablets to the Reference Listed Drug (RLD), Felbatol® (felbamate) 600 mg tablets 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-09-004 |
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 = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Dinesh Kamath |
Global Hospitals |
No 439, Cheran Nagar,Perumbakam-600100
Chennai
TAMIL NADU |
+91 44 22777000
+91 44 22777000
gcrschennai@gcrs-online.com |
| Dr Anil Jain |
Jain Neuro Centre |
177-178,Jagriti Enclave,Vikas Marg Extension, Vikas Road-110 092
New Delhi
DELHI |
+91 11 22144946
+91 11 22161561
jainhospitaldelhi@hotmail.com |
| Dr Lekha Pandit |
Justice K.S.Hegde charitable Hospital |
Derakatle,-575004
Bangalore
KARNATAKA |
91-824-2203747
91-824-2203747
panditmng@gmail.com |
| Dr. Suresh B. V. |
Kasturaba Medical College and Hospital |
Department of Neurology,Attavar-575001
Bangalore
KARNATAKA |
+ 91 824 2445858
+ 91 824 2425092
hegde_suresh@yahoo.co.in |
| Dr. Shankara Nellikunja |
Mallikatta Neuro Centre |
Opp. Mallikatta Circle,,Kadri-575002
Bangalore
KARNATAKA |
+ 91 824-244933
+ 91 824 2425092
shankarmnl@hotmail.com |
| Dr. R. Umashankar |
Padmashree Diagnostics |
No 97, 17th Cross MC Layout,Chord Road, Vijayanagar-560040
Bangalore
KARNATAKA |
+91 80 23354249
+91 80-23354249
umaneuro@yahoo.co.in |
| Dr. Jitender Singh |
Radhaswami nursing home |
Sardar Patel stadium road,Navrangpura-380014
Ahmadabad
GUJARAT |
+91 79-26467048
+91 79-26467048
myjitender1975@gmail.com |
| Dr A. K. Roy |
St. Johns Medical College Hospital |
Sarjapur Road,Koramangala-560034
Bangalore
KARNATAKA |
+ 91 80 22065330
+91 80 25634479
roy_ajit@hotmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Clinicom Ethics Committee for Jain Hospital |
Approved |
| Clinicom Ethics Committee for Padmashree Diagnostics |
Approved |
| Clinicom Ethics Committee for Radhaswami nursing home |
Approved |
| Global Hospitals Ethics Committee for Global Hospitals |
Approved |
| K.S.Hegde Ethics Committee Justice K.S.Hegde Charitable Hospital |
Approved |
| KMC Ethics Committee for Kasturaba Medical College and Hospital |
Approved |
| Mallikatta Ethics Committee for Mallikatta Neuro Centre |
Approved |
| St. Johns Ethics Committee for St. Johns Medical College Hospital |
Submittted/Under Review |
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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 tablets |
Oral doses of 600 mg or multiples of 600 mg felbamate 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 tablets |
Oral doses of 600 mg or multiples of 600 mg Felbatol® 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 |
65.00 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 |
Repeated post dose blood sampling till 8 hours after dosing |
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Secondary Outcome
Modification(s)
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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)
Modification(s)
|
03/09/2009 |
| 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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Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
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None Yet |
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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 mg tablets (test) to the Reference Listed Drug Felbatol® (felbamate) 600 mg tablets 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) |