Clinical Trial

Bioequivalence Study of Pramipexole Dihydrochloride Extended-release Tablets in Healthy Chinese Subjects

Completed Phase 1
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-04-02.
Trial Details
NCT Number NCT07519278
Lead Sponsor Haisco Pharmaceutical Group Co., Ltd.
Conditions Healthy
Enrollment 49 participants
Start Date 2017-03-16
Primary Completion 2017-04-11 (estimated)
Study Completion 2018-02-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-14