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Last update 23 May 2026
Hunan Jiudian Pharmaceutical Co., Ltd.
Last update 23 May 2026
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Skin and Musculoskeletal Diseases
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CTR20255094
苯磺酸美洛加巴林片在中国健康受试者中进行的单中心、随机、开放、单次（空腹/餐后）口服给药、两制剂、两序列、两周期、交叉的人体生物等效性试验。
[Translation] Merogabalin besylate tablets were used in a single-center, randomized, open-label, single-dose (fasting/postprandial) oral administration, two-formulation, two-sequence, two-period, crossover human bioequivalence trial in healthy subjects in China.
CTR20253789
酮咯酸氨丁三醇片在空腹和餐后条件下的人体生物等效性试验
[Translation] Bioequivalence study of ketorolac tromethamine tablets in humans under fasting and fed conditions
CTR20253676
健康受试者餐后单次口服磷酸奥司他韦胶囊的随机、开放、两序列、两周期、双交叉设计的生物等效性试验
[Translation] A randomized, open-label, two-sequence, two-period, double-crossover bioequivalence study of a single oral dose of oseltamivir phosphate capsules in healthy volunteers after a meal
100 Clinical Results associated with Hunan Jiudian Pharmaceutical Co., Ltd.
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01 May 2024Pharmaceutical research
Nonlinear Pharmacokinetics of Topical Flurbiprofen Gel in a Phase I Study Among Chinese Healthy Adults
Article
Author: Xiao, Wending ; Cheng, Zeneng ; Xie, Feifan ; Zhu, Zhihong ; Liu, Feiyan
INTRODUCTION:
PDX-02 (Flurbiprofen sodium) is a topical nonsteroidal anti-inflammatory drug in gel formulation for local analgesia and anti-inflammation. A Phase I clinical trial was conducted to assess the safety, tolerability, and pharmacokinetics of single and multiple doses of PDX-02 gel in Chinese healthy adults.
METHODS:
The trial comprised three parts: (1) a single-dose ascending study with three dose levels (0.5%, 1% to 2% PDX-02 gel) applied on a 136 cm2 skin area; (2) a multiple-dose study with either 1% or 2% PDX-02 gel applied on a 136 cm2 skin area for 7 consecutive days; and (3) a high dose group with 2% PDX-02 gel on an 816 cm2 skin area and a frequent multiple dose group with 2% PDX-02 gel on a 272 cm2 skin area four times a day for 7 consecutive days. The safety, tolerability and pharmacokinetics of the PDX-02 gel were evaluated in each part.
RESULTS:
A total of sixty participants completed the trial, with all adverse events recovered and all positive skin reaction being transient and recovered. The overall absorption of topical PDX-02 gel was slow with a mean peak time exceeding 9 h. The elimination rate remained consistent between dose groups. A less-than-dose-proportional nonlinear pharmacokinetics relationship was observed within the studied dose range, and this is likely due to the autoinduction of skin first-pass metabolism.
CONCLUSION:
The topical PDX-02 gel showed favorable safety and tolerability in both single and multiple dosing studies, with a less-than-dose-proportional nonlinear pharmacokinetics observed.
100 Deals associated with Hunan Jiudian Pharmaceutical Co., Ltd.
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100 Translational Medicine associated with Hunan Jiudian Pharmaceutical Co., Ltd.
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Pipeline Snapshot as of 26 May 2026
The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3
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