NCT07519278

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Test formulation（pramipexole dihydrochloride extended-release tablets）	Test formulation (pramipexole dihydrochloride extended-release tablets, Haisco Pharmaceutical Group Co., Ltd), A single oral dose of 0.375 mg, taken with 240mL of water
DRUG	Reference formulation（MIRAPEX ER®）	Reference formulation (pramipexole dihydrochloride extended-release tablets, Boehringer Ingelheim GmbH of Germany), A single oral dose of 0.375 mg, taken with 240mL of water

Timeline

• Start date: 2017-03-16
• Primary completion: 2017-04-11
• Completion: 2018-02-12
• First posted: 2026-04-09
• Last updated: 2026-04-14

Locations

1 site across 1 country: China