Product

Gliclazide

Pharmaceutical Form

Tablets

Strengths

30 mg

Release Characteristics

Sustained Release (like Servier’s – France – DIAMICRON modified relea-se 30 mg tablets)

Indications

Type II diabetes

Posology

Once daily

Raw Material

DMF available

Chemical Pharmaceutical Dossier

Available in CTD format

Parmacokinetics

Available, carried out by Farmovs-Parexel (South Africa): Single dose under fasting conditions bioequivalence study on 30 healthy vol-unteers vs. Servier’s (France) DIAMICRON modified release 30 mg tablets. Single dose under fed conditions bioequiva-lence study on 30 healthy volunteers vs. Servier’s (France) DIAMICRON modified release 30 mg tablets. Multiple dose bioequivalence study under fasting conditions on 30 healthy volunteers vs. Servier’s (France) DIAMICRON modified release 30 mg tablets.

Registration underway

Croatia, Egypt, Italy, Malaysia, Serbia, Spain, Sudan, Venezuela, South Africa, Turkey, Tunisia.

Marketing

France

Notes

The formulation is patent-pending worldwide