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

Phase 1

Completed

• Conditions: Refractory Epilepsy

• Registration Number: CTRI/2009/091/000708
• Lead Sponsor: Amneal Pharmaceuticals

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-12
• Last Update Posted: 2014-11-08

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• 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.

Exclusion Criteria

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.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AUCss, Cmax and Cmin	Repeated post dose blood sampling till 8 hours after dosing

Secondary Outcome Measures

Name	Time	Method
Tmax and % Fluctuation	Repeated post dose blood sampling till 8 hours after dosing

Trial Locations

Locations (1)

Padmashree Diagnostics; 🇮🇳 Bangalore, KARNATAKA, India

Padmashree Diagnostics

🇮🇳Bangalore, KARNATAKA, India

Dr R Umashankar

Principal investigator

80-23354249

umaneuro@yahoo.co.in