A clinical trial to evaluate the blood levels of Felbamate after administration of Amneal Pharmaceuticals felbamate suspension (test) compared to the Reference Drug FelbatolÂ® suspension (felbamate) in epilepsy patients

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), FelbatolÂ® (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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000708

Enrollment

Registered

2009-10-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Refractory Epilepsy

Interventions

Intervention1: 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 perio

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
AUCss, Cmax and Cmin Timepoint: Repeated post dose blood sampling till 8 hours after dosing	—

Secondary

Measure	Time frame
Tmax and % FluctuationTimepoint: Repeated post dose blood sampling till 8 hours after dosing	—

Countries

India

Contacts

Public ContactVinod M

Manipal Acunova

shalini.agarwal@ecronacunova.com91-80-66915776

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026