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

NCT07519278 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2026-04-14

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Haisco Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-16
Primary Completion
2017-04-11
Completion
2018-02-12

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07519278 on ClinicalTrials.gov