Product

Diltiazem HCI

Pharmaceutical Form

Capsules containing pellets

Strengths

200 mg, 300 mg

Release Characteristics

Like Mono-Tildiem LP (Sanofi Aventis, France)

Posology

Once daily

Raw Material

DMF available

Chemical Pharmaceutical Dossier

Available

Bioequivalence Studies

Bioequivalence Studies on 30 healthy volunteers vs. Sanofi Aventis (France) Mono-Tildiem LP, Diltiazem HCI prolonged release 300 mg capsules:

- single dose under fasting conditions

- single dose under fed conditions

- steady state