Trial reportBMC pharmacology & toxicology2026
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.
Trial report in BMC pharmacology & toxicology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07519278 (Comparative Pharmacokinetics for Bioequivalence of Pramipexole Dihydrochloride Extended-Release Tablets in Fasting and Fed Chinese Healthy Volunteers), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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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
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Authors and funding
7 authors.
Funding
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Abstract
backgroundWe aimed to compare pharmacokinetic (PK) profiles and establish bioequivalence between generic and original pramipexole extended-release (ER) tablets in healthy Chinese volunteers under fasting and fed conditions.
methodsThis investigation consisted of two randomized, open-label, single-dose, two-period, crossover studies. In the first period of each study, a single oral dose (0.375 mg) of the test or reference pramipexole ER tablets was randomly assigned (1:1) to healthy Chinese volunteers. The investigator collected blood samples before and after dosing for up to 72 h and assessed the safety profile. The central laboratory staff, unaware of the study procedures, determined the plasma pramipexole based on a validated LC-MS/MS method. Primary PK endpoints, including peak concentration (C
resultsIn the fasting study (n = 24), C
conclusionFindings in comparative PK profiles suggested bioequivalence between the generic and original pramipexole ER tablets in healthy Chinese volunteers under fasting and fed conditions. Pramipexole ER tablets had a favorable safety profile. CLINICAL
trial registrationThis study was prospectively registered (Registration number: CTR20170248; Date of registration: February 28, 2016) in the Chinese Clinical Trial Registration Platform ( http://www.chinadrugtrials.org.cn ). This trial registry is recognized and regulated by the Chinese National Medical Products Administration (NMPA). This study was retrospectively registered on ClinicalTrials.gov (Registration Number: NCT07519278; Date of registration: April 2, 2026) in the US ( www. CLINICALTRIALS: gov ). The two PK studies were conducted between March 22, 2017, and June 13, 2017.
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