A clinical trial to evaluate the blood levels of Felbamate after administration of Amneal Pharmaceuticals felbamate tablets (test) compared to the Reference Drug FelbatolÂ® tablets (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 tablets to the Reference Listed Drug (RLD), FelbatolÂ® (felbamate) 600 mg tablets 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/2009/091/000706

Enrollment

Registered

2009-09-16

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 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 Control Inter

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 CminTimepoint: Repeated post dose blood sampling till 8 hours after dosing	—

Secondary

Measure	Time frame
Tmax and % Fluctuation.Timepoint: 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