clinical trial · NCT07519278
Bioequivalence Study of Pramipexole Dihydrochloride Extended-release Tablets in Healthy Chinese Subjects
Haisco Pharmaceutical Group Co., Ltd.·phase1·completed·n = 49
HealthyTest formulation（pramipexole dihydrochloride extended-release tablets）Reference formulation（MIRAPEX ER®）
brief summary
The study compared pramipexole dihydrochloride extended-release tablets (Test formulation) by Haisco Pharmaceutical Group Co., Ltd. with the reference formulation (MIRAPEX ER®，Boehringer Ingelheim GmbH of Germany) to evaluate the bioequivalence of single dose in Chinese healthy subjects under fasting and fed conditions.
started
Mar 16, 2017
primary completion
Apr 11, 2017
completion
Feb 12, 2018
last updated
Apr 14, 2026
official title
Comparative Pharmacokinetics for Bioequivalence of Pramipexole Dihydrochloride Extended-Release Tablets in Fasting and Fed Chinese Healthy Volunteers: A Randomized, Open-label, Single-dose, Crossover Study
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol