Clinical Trial: Bioequivalence Study of Dronedarone Hydrochloride Tablets

U.S., Feb. 10 -- ClinicalTrials.gov registry received information related to the study (NCT07396519) titled 'Bioequivalence Study of Dronedarone Hydrochloride Tablets' on Jan. 27.

Brief Summary: The test formulation of Dronedarone Hydrochloride Tablets (400 mg) is bioequivalent to the reference formulation (MULTAQ(R)) in healthy Chinese subjects under fed conditions.

Study Start Date: Nov. 14, 2022

Study Type: INTERVENTIONAL

Condition: Atrial Fibrillation (AF)

Intervention: DRUG: Dronedarone Hydrochloride Tablets

Test Product. Manufacturer: Shandong New Time Pharmaceutical Co., Ltd. Dosage Form/Strength: 400 mg tablet Administration: Single oral dose of 400 mg (1 tablet).

DRUG: MULTAQ(R) (Dronedarone Hydrochloride Tablets)

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