A Randomized, Placebo-Controlled, Double-Blind, Crossover Comparative Study of the Effect of Acotiamide on Gastrointestinal Symptoms in Patients with Myasthenia Gravis - ACTMG
Main research purpose: To investigate the effect of acotiamide hydrochloride tablets (test preparation T, specification: 100mg) on a single oral dose of acotiamide hydrochloride tablet (test preparation T, specification: 100mg) produced by Beijing Yabao Biopharmaceutical Co., Ltd. under fasting and postprandial conditions. Under the same conditions, the pharmacokinetic characteristics of acotiamide hydrochloride tablets (reference preparation R, trade name: Acofide®, specification: 100 mg) produced by Japan Zeri New Pharmaceutical Co., Ltd. produced by a single oral administration were evaluated. Bioequivalence provides the basis for the registration application of the test product. Secondary research purpose: To observe healthy subjects taking 100 mg of test preparation acoteamide hydrochloride tablets (specification: 100 mg) and reference preparation acoteamide hydrochloride tablets (trade name: Safety of Acofide®, Strength: 100mg).
Main research purpose: To evaluate the relationship between the test preparation acotiamide hydrochloride tablets (specification: 0.1g) produced by Yichang Renfu Pharmaceutical Co. Trader: Pharmacokinetic characteristics and bioequivalence of reference preparation Acofide (specification: 100 mg) of ゼア新薬 Industries Co., Ltd.
Secondary research objectives: To study the safety of a single oral dose of the test preparation acoteamide hydrochloride tablets (strength: 0.1g) and the reference preparation Acofide (strength: 100 mg) in healthy subjects.
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