Bioequivalence study of low dose drospirenone/ethinyl estradiol 3 mg/0.03 mg film tablets under fasting conditions in Turkish healthy female subjects.

IF 2.9 4区医学 Q2 PHARMACOLOGY & PHARMACY

Pharmacology Research & Perspectives Pub Date : 2024-08-01 DOI:10.1002/prp2.1253

Ahmet Inal, Zafer Sezer, Berna Uluözlü, Melih Oflas, Martin Reinsch, Wolfgang Martin, Mümtaz M Mazicioglu, Selma Alime Koru

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引用次数: 0

Abstract

This bioequivalence research aims to evaluate the relative bioavailability and pharmacokinetic characteristics of ethinyl estradiol and drospirenone in the test preparation in comparison to the reference preparation during fasting conditions. A liquid chromatography method with tandem mass spectrometry was used to determine the concentrations of drospirenone and ethinyl estradiol in plasma. The pharmacokinetic parameters that were analyzed were the maximum plasma concentration (C_max), time to achieve C_max (t_max), elimination half life, and area under the concentration time curve of plasma (AUC_0-t, AUC_0-∞ for ethinyl estradiol, and AUC_0-72h for drospirenone). Both the AUC and C_max parameters were determined to be between 80.00% and 125.00% (90% confidence intervals), which is the acceptable range. Based on the study findings, it was concluded that the test formulation, which includes 3 mg of drospirenone and 0.03 mg of ethinyl estradiol, demonstrated bioequivalence when compared to the reference formulation.

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空腹条件下土耳其健康女性受试者服用低剂量屈螺酮/炔雌醇 3 毫克/0.03 毫克薄膜片剂的生物等效性研究。

这项生物等效性研究旨在评估试验制剂与参比制剂在空腹状态下炔雌醇和屈螺酮的相对生物利用度和药代动力学特征。采用液相色谱法和串联质谱法测定血浆中屈螺酮和炔雌醇的浓度。分析的药代动力学参数包括最大血浆浓度（Cmax）、达到 Cmax 的时间（tmax）、消除半衰期和血浆浓度时间曲线下面积（AUC0-t，炔雌醇为 AUC0-∞，屈螺酮为 AUC0-72h）。经测定，AUC 和 Cmax 参数介于 80.00% 和 125.00% 之间（90% 置信区间），属于可接受范围。研究结果表明，与参比制剂相比，试验制剂（包括 3 毫克屈螺酮和 0.03 毫克炔雌醇）具有生物等效性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pharmacology Research & Perspectives Pharmacology, Toxicology and Pharmaceutics-General Pharmacology, Toxicology and Pharmaceutics

CiteScore

5.30

自引率

3.80%

发文量

120

审稿时长

20 weeks

期刊介绍： PR&P is jointly published by the American Society for Pharmacology and Experimental Therapeutics (ASPET), the British Pharmacological Society (BPS), and Wiley. PR&P is a bi-monthly open access journal that publishes a range of article types, including: target validation (preclinical papers that show a hypothesis is incorrect or papers on drugs that have failed in early clinical development); drug discovery reviews (strategy, hypotheses, and data resulting in a successful therapeutic drug); frontiers in translational medicine (drug and target validation for an unmet therapeutic need); pharmacological hypotheses (reviews that are oriented to inform a novel hypothesis); and replication studies (work that refutes key findings [failed replication] and work that validates key findings). PR&P publishes papers submitted directly to the journal and those referred from the journals of ASPET and the BPS