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COMPLETED
NCT07519278
PHASE1

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

Sponsor: Haisco Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

49

Start Date

2017-03-16

Completion Date

2018-02-12

Last Updated

2026-04-14

Healthy Volunteers

Yes

Conditions

Interventions

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

Locations (1)

The General Hospital of Western Theater Command PLA

Chengdu, Sichuan, China