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

BACKGROUND: We 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. METHODS: ), were calculated and presented as mean ± SD using non-compartmental analysis with geometric mean ratios (90% confidence intervals) between the two study products. RESULTS: between the two products was within 80.0% - 125.0% for bioequivalence. There were no serious adverse events reported in the fasting and fed studies. CONCLUSION: Findings 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 REGISTRATION: This 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.