Product

Bezafibrate

Pharmaceutical Form

Tablets

Strengths

400 mg

Release Characteristics

Sustained Release (like Böhringer Mannheim’s – UK – BEZALIP MONO – 400 mg tablets)

Posology

Once daily

Raw Material

DMF available

Chemical Pharmaceutical Dossier

Available in CTD format

Parmacokinetics

Multiple dose (steady state – 6 days) two-way crossover bioequivalence study on 24 healthy volunteers vs. Böhringer Mannheim (UK) BEZALIP MONO 400 mg bezafibrate sustained release 400 mg tablets.

Single dose food interaction three-way study on 24 healthy volunteers.

Registration underway

Israel, New Zealand

Marketing

Italy, Republic of South Africa, United Kingdom.

Notes

Free Sale Certificate available