Comparative Bioavailability Study Between Etoricoxib/Betamethasone Tablets 90 mg/0,25 mg From Laboratorios Silanes, SA de CV vs Etoricoxib Tablets 90 mg (Arcoxia®) and Betamethasone Solution 50 mg/100 mL (Celestone® Pediatric) From Laboratorios Schering-Plough SA de CV, Administered Individually or in Combination, in an Open-label, Randomized, Single-dose, 3-period, 6-sequence, 3-treatment Design in Healthy Subjects of Both Genders Under Fasting Conditions

Laboratorios Silanes S.A. de C.V.1 个研究点分布在 1 个国家目标入组 42 人开始时间: 2022年10月24日最近更新: 2026年3月6日

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Laboratorios Silanes S.A. de C.V.
入组人数: 42
试验地点: 1
主要终点: Determine the Cmax.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study seeks to evaluate the comparative bioavailability of etoricoxib/betamethasone tablets 90 mg/0.25 mg test drug, administered in fixed combination vs. etoricoxib tablets 90 mg (Arcoxia®) reference drug, and betamethasone solution 50 mg/100 mL (Celestone® Pediatric) reference drug, administered individually, in a single dose, to 42 healthy mexican research subjects of both genders, under fasting conditions.

详细描述

The purpose of this study is to determine whether there are differences in the magnitude and rate of absorption between the test drug and the reference drugs. The study will be cross-over, randomized, with three periods, three treatments, six sequences, truncated at 72 hours in 42 healthy subjetcs, with a single dose of etoricoxib/betamethasone 90/0.25 mg tablet administered in combination or a tablet of etoricoxib 90 mg, or betamethasone solution 50 mg/100 mL (Celestone® Pediatric) administered individually under fasting conditions, with 250 mL of water and a 14-day washout period between each dose of the test product.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 55 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•The subjects must have been accepted by the COFEPRIS research subjects registration database.
•Subjects without a subordinate relationship with the researchers.
•Subjects who have given informed consent in writing.
•Subjects of both genders, aged between 18 and 55 years, Mexicans. - -Subjects with no background of hypersensitivity or allergies to the drug under study or related drugs.
•Body mass index between 18 and 27 kg/m
•Healthy subjects, according to the results of the complete clinical history, electrocardiogram and the integration of the results of the clinical analyses, carried out in certified clinical laboratories, without alterations that require a medical intervention as a consequence.
•Subjects with negative results for immunological tests (Anti-HIV, Anti-hepatitis B and C, VDRL).
•Subjects with negative results in drug abuse screening tests: tetrahydrocannabinoids, cocaine and amphetamines.
•Negative (qualitative) pregnancy test for women of childbearing potential without Bilateral tubal obstruction or hysterectomy.
•In the case of women of childbearing age, they must have a birth control method, including barrier methods, non-hormonal intrauterine device, or bilateral tubal obstruction.

排除标准

•- Subjects with recent history or physical examination evidence of gastrointestinal, renal, hepatic, endocrine, respiratory, cardiovascular, dermatological, or hematological disease that could affect the pharmacokinetic study of the product in research.
•Subjects who have been exposed to drugs known as liver enzyme inducers or inhibitors or who have taken drugs potentially toxic within 30 days before the start of the study.
•Subjects who have received any medication during the 7 days before the start of the study.
•Subjects who have been hospitalized for any problem during the three months before the start of the study.
•Subjects who have been rejected by the registry database of research subjects of COFEPRIS, for having participated in a clinical study within the three months prior to the start of the study.
•Subjects who have received investigational drugs within the previous 60 days th the start of the study.
•Subjects allergic to the study drug or related drugs.
•Subjects who have ingested alcohol or drinks containing xanthines (coffee, tea, cocoa, chocolate, cola) or who have eaten charcoal-grilled food or grapefruit juice , at least 10 hours before the start of the study or who have smoked tobacco 24 hours before to the start of the internment period.
•Subjects who have donated or lost 450 mL or more of blood within the previous 60 days of the beginning of the study.
•Subjects with a history of drug and/or alcohol abuse according to the DSM-IV-TR Criteria.
•Research subjects who presents alterations in the vital signs recorded during the selection.

研究组 & 干预措施

Group A: Etoricoxib / Betamethasone

Experimental

Group A: Etoricoxib/ Betamethasone in fixed dose combination. Pharmaceutical form: Tablet.

Each tablet contains:

Etoricoxib 90 mg
Betamethasone 0.25 mg Administration way: oral.

干预措施: A1: Etoricoxib / Betamethasone in fixed dose combination tablet. (Laboratorios Silanes S.A. de C.V.) (Drug)

Group B: Etoricoxib

Active Comparator

Group B: Etoricoxib Pharmaceutical form: Tablet. Formula: Each tablet contains 90 mg of Etoricoxib. Dosage: 1 tablet of 90 mg. Administration way: Oral.

干预措施: A2: Etoricoxib (Arcoxia®, Laboratorios Schering-Plough, S.A. de C.V.) (Drug)

Group C: Betamethasone

Active Comparator

Group C: Betamethasone Pharmaceutical form: Solution. Formula: Each 100 mL of solution contains 50 mg of betamethasone. Dosage: 0.5 mL equivalent to 0.25 mg of betamethasone. Administration way: Oral.

干预措施: A3: Betamethasone (Celestone® Pediatric, Laboratorios Schering-Plough, S.A. de C.V.) (Drug)