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Pharmacokinetics and Bioequivalence of Dienogest in Healthy Bangladeshi Female Volunteers: An Open-Label, Single-Dose, Randomized, Two-Way Crossover Study

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Open Journal of Obstetrics and Gynecology 2024年第5期14卷 779-789页

作者： Nusrat Mahmud Nafisa Ahamed Uttom Kumar Bhowmik Sabrina Akter Tushi nayan ghosh Nithon Chandra Sahana Arifa Akram Md. Alimur Reza BIRDEM General Hospital Dhaka Bangladesh Medical College for Women & Hospital Dhaka Bangladesh Novus Clinical Research Services Ltd. Dhaka Bangladesh National Institute of Laboratory Medicine & Referral Centre (NILMRC) Dhaka Bangladesh

Background: Dienogest is a potential treatment for pelvic pain associated with endometriosis, a condition of significant concern in gynaecology. The current study was conducted as a crossover-randomized bioequivalence assessment of two oral Dienogest 2 mg formulations, aiming to provide valuable insights for healthcare professionals and researchers in this field. Objective: The primary aim of this research was to evaluate and compare the pharmacokinetic characteristics of Dienogest 2 mg tablets. Dinogest (Dienogest 2 mg) tablets, manufactured by Nuvista Pharma Limited in Bangladesh, and Visanne (Dienogest 2 mg) tablets, manufactured by Bayer Pharma in Germany, were the test and reference formulations, respectively. Materials and Method: The study was an open-label, balanced, randomized, two treatments, two sequences, two periods, two-way crossover, laboratory blind, single oral dose bioequivalence study conducted in healthy adult females under fasting conditions. The study was carried out on 13 healthy, non-pregnant female subjects, and all the subjects completed both study periods with a 15-day washout in between. Randomization was used to assign the test and reference formulations to the subjects. Following each oral administration, a series of blood samples were obtained at different time intervals from pre-dose to 72 hours post-dose and analyzed for Dienogest concentrations using a validated bio-analytical method. A standard non-compartmental model was used to analyze the pharmacokinetic parameters. The primary pharmacokinetic parameters were peak plasma drug concentration (Cmax), the area under the plasma concentration-time curve from time zero to time t (AUC0–t), and AUC from t = 0 to infinity (AUC0–∞). The other PK parameters included time to reach Cmax (Tmax), terminal elimination rate constant (Kel), and half-life (t1/2). Result: The ratios and 90% CI for the geometric mean test/re

关键词： Dienogest Bioequivalence Study Endometriosis Novus CRSL

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