Scholarlink

Background <p>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.</p> Methods <p>This 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&#xa0;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&#xa0;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<sub>max</sub>) and the areas under the plasma concentration-time curve (AUC<sub>0−t</sub>, AUC<sub>0−∞</sub>), were calculated and presented as mean ± SD using non-compartmental analysis with geometric mean ratios (90% confidence intervals) between the two study products.</p> Results <p>In the fasting study (<i>n</i> = 24), C<sub>max</sub>, AUC<sub>0−t</sub>, and AUC<sub>0−∞</sub> were 0.45 ± 0.12 ng/mL, 9.46 ± 2.70&#xa0;h·ng/mL, and 9.75 ± 2.72&#xa0;h·ng/mL, following a single dose of the test product. In the fed study (<i>n</i> = 24), PK profiles (C<sub>max</sub>, AUC<sub>0−t</sub>, and AUC<sub>0−∞</sub>: 0.52 ± 0.11 ng/mL, 9.52 ± 2.01&#xa0;h·ng/mL, and 9.82 ± 2.05&#xa0;h·ng/mL) were not affected by a high-fat diet in participants with a single dose of the test product. The test and reference products had comparable PK profiles in the two studies. The 90% CI of the GMR in C<sub>max</sub>, AUC<sub>0−t</sub>, and AUC<sub>0−∞</sub> 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.</p> Conclusion <p>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.</p> Clinical trial registration <p>This study was prospectively registered (Registration number: CTR20170248; Date of registration: February 28, 2016) in the Chinese Clinical Trial Registration Platform (<a href="http://www.chinadrugtrials.org.cn">http://www.chinadrugtrials.org.cn</a>). 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 (<a href="http://www.clinicaltrials.gov">www.clinicaltrials.gov</a>). The two PK studies were conducted between March 22, 2017, and June 13, 2017.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

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

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年5月11日

查看全文
  • Qian Chen,
  • Hui-qing Shi,
  • Yi-fang Chen,
  • Wei Zhang,
  • Lan Ye,
  • Ya-ming Li,
  • Ting-ting Hu

摘要

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

This 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 (Cmax) and the areas under the plasma concentration-time curve (AUC0−t, AUC0−∞), were calculated and presented as mean ± SD using non-compartmental analysis with geometric mean ratios (90% confidence intervals) between the two study products.

Results

In the fasting study (n = 24), Cmax, AUC0−t, and AUC0−∞ were 0.45 ± 0.12 ng/mL, 9.46 ± 2.70 h·ng/mL, and 9.75 ± 2.72 h·ng/mL, following a single dose of the test product. In the fed study (n = 24), PK profiles (Cmax, AUC0−t, and AUC0−∞: 0.52 ± 0.11 ng/mL, 9.52 ± 2.01 h·ng/mL, and 9.82 ± 2.05 h·ng/mL) were not affected by a high-fat diet in participants with a single dose of the test product. The test and reference products had comparable PK profiles in the two studies. The 90% CI of the GMR in Cmax, AUC0−t, and AUC0−∞ 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.