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1 (a) Participants received 60 mg/70 kg (low), and 120 mg/70 kg (high) codeine sulfate on Tuesday, Thursday, and Monday of weeks 4 and 8, respectively.
Codeine Sulfate Tablets USP is a schedule II controlled substance, 15mg, 30mg and 60mg, the therapeutic equivalent to the reference listed drug, Codeine Sulfate Tablets USP 15mg, 30mg and 60mg, of Roxane Laboratories.
The first study presented today was conducted in 12 healthy male volunteers in a double-blind crossover design with indiplon modified release 30 mg, codeine sulfate 60 mg (as a positive control), or placebo.
Codeine sulfate for oral human administration was obtained from Roxane Laboratories and was prepared in polished lactose capsules (Amend Drug and Chemical Co.
4) Internal Analgesic Drug Products: Aminobenzoic Acid, Antipyrine, Aspirin (Aluminum), Calcium Salicylate, Codeine, Codeine Phosphate, Codeine Sulfate, Iodoantipyrine, Lysine Aspirin, Methapyrilene Fumarate, Phenacetin, Pheniramine Maleate, Pyrilamine Maleate, Quinine, Salsalate Sodium Aminobenzoate.