U.S., Feb. 10 -- ClinicalTrials.gov registry received information related to the study (NCT07396506) titled 'Bioequivalence Study of Dronedarone Hydrochloride Tablets in Healthy Subjects Under Fasting Conditions' 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 fasting conditions.
Study Start Date: June 05, 2023
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: MULTA...