Fujian Jushen Pharmaceutical Co., Ltd.

A bioequivalence study was conducted on Chinese healthy adult subjects with a single oral dose of acetaminophen and dihydrocodeine tablets (test preparation T, produced by Fujian Jushen Pharmaceutical Co., Ltd., specifications: acetaminophen 500 mg and dihydrocodeine tartrate 10 mg) and acetaminophen and dihydrocodeine tablets (reference preparation R, licensed by Actavis UK Limited/Accord UK Ltd, produced by Accord UK Ltd, trade name: Co-dydramol®, specifications: acetaminophen 500 mg; dihydrocodeine tartrate 10 mg) under fasting conditions to investigate the absorption rate and extent of the test preparation and the reference preparation under fasting conditions and to evaluate whether the test preparation and the reference preparation are bioequivalent. Secondary study objectives: To observe the safety of the test preparation acetaminophen and dihydrocodeine tablets and the reference preparation acetaminophen and dihydrocodeine tablets (Co-dydramol®) in healthy subjects.

A bioequivalence study was conducted on healthy Chinese adult subjects in the fasting/postprandial state by taking a single oral dose of acetaminophen and dihydrocodeine tablets (test preparation T, produced by Fujian Jushen Pharmaceutical Co., Ltd., specifications: acetaminophen 500mg and dihydrocodeine tartrate 10mg) and acetaminophen and dihydrocodeine tablets (reference preparation R, licensed by Actavis UK Limited/Accord UK Ltd, produced by Accord UK Ltd, trade name: Co-dydramol®, specifications: acetaminophen 500mg; dihydrocodeine tartrate 10mg) to investigate the absorption rate and extent of the test preparation and the reference preparation under fasting/postprandial conditions, and to evaluate whether the test preparation and the reference preparation are bioequivalent. Secondary study objectives: To observe the safety of the test preparation acetaminophen and dihydrocodeine tablets and the reference preparation acetaminophen and dihydrocodeine tablets (Co-dydramol®) in healthy subjects.