Product

Pentoxifylline

Pharmaceutical Form

Tablets

Strengths

400 mg

Release Characteristics

Sustained Release (like Höchst – UK – TRENTAL 400 tablets)

Posology

Two or three tablets daily

Raw Material

DMF available

Chemical Pharmaceutical Dossier

Available

Parmacokinetics

Multiple dose (steady state – 6 days) two-way crossover bioequivalence study on 24 healthy volunteers vs. Höchst’s (UK) TRENTAL 400, pen-toxifylline sustained release 400 mg tablets. Single dose three-way fasting / non-fasting bioequivalence study on 24 healthy volunteers vs. Höchst’s (UK) TRENTAL 400, pentoxifylline sus-tained release 400 mg tablets.

Registration underway

Republic of El Salvador, Italy, Roma-nia, United Kingdom.

Marketing

Azerbaijan, Portugal, Republic of South Africa, Spain.

Notes

Free Sale Certificate available