Pharmacokinetic Evaluation of Lansoprazole/sodium Bicarbonate capsule compared with Lansoprazole capsule in Healthy Chinese Adults

Author(s): Meihua Lin, Yunliang Zheng, You Zhai, Chang Xu, Minglan Wu, Qian Huang, Guolan Wu, Jianzhong Shentu, Jian Liu, Lihua Wu

Objective: This study was conducted to characterize the pharmacokinetic (PK) and safety profiles of the investigational immediate-released (IR) formulation containing lansoprazole/sodium bicarbonate (30/1100 mg) in healthy Chinese adult volunteers, as compared with the commercially available enteric-coated formulation of lansoprazole.

Methods: A single-dose, two-treatment, three-period, partial-replicate, cross-over study was conducted. Thirty qualified subjects were randomized to one of the following dosing sequences: TRR, RTR or RRT (T refers to the test drug and R is the reference) in equal numbers. A single dose of the T/R was administrated orally in fasted condition and the washout period was scheduled as 6 days. Pharmacokinetic and safety were assessed.

Results: It was observed that the PK parameter Tmax was shortened while the Cmax heightened (p<0.001) in the test product compared with reference formulation. The geometric mean ratio (GMR) of AUC0-t and AUC0-∞ was 1.1205 and 1.1118, respectively. 90% CIs for the GMR all fell within the range of 80% to 125%. Both formulations were well tolerated.

Conclusions: The two products were bioequivalent as to systemic exposure based on AUC0-t and AUC0-∞, while the IR formulation had a faster absorption and probably prompt onset of action.

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