CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 42 enrolled
Drug / intervention
A1: Etoricoxib / Tramadol Fixed dose combination +2 moredrug
Likely dose
A1: Etoricoxib / Tramadol Fixed dose combination 90 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05533073
NCT05533073Phase 1Completed

Comparative Bioavailability Study Between Etoricoxib 90 mg and Tramadol 50 mg, Administered Individually or in Combination, Single Dose in Healthy Subjects of Both Genders Under Fasting Conditions

Laboratorios Silanes S.A. de C.V.·interventional·Posted Sep 8, 2022·Updated Sep 9, 2022

In Brief

A Phase 1 clinical trial evaluating A1: Etoricoxib / Tramadol Fixed dose combination, A2: Etoricoxib, and 1 other intervention for Healthy. Completed, enrolled 42 participants across 1 site.

Detailed Summary

Study carried out in the Clinical and Analytical Unit of the Department of Pharmacology and Toxicology of the Faculty of Medicine of the Autonomous University of Nuevo León, with the objective of comparing the bioavailability (Cmax, AUC) of an oral formulation containing Etoricoxib 90 mg / Tramadol 50 mg in combination with that of two oral formulations, Etoricoxib 90 mg or Tramadol 50 mg, administered as a single dose, in healthy subjects under fasting conditions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesMexico
Collaborators--

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedSep 8, 2022
Enrollment StartAug 3, 2020
Primary CompletionSep 7, 2020
Study CompletionNov 30, 2020
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 3.8 years ago

Interventions

A1: Etoricoxib / Tramadol Fixed dose combinationdrug

Sachet with granules (Laboratorios Silanes S.A. de C.V.). Formula : 90 mg/ 50 mg Pharmaceutical Form: Sachet with granules Dosage: 100 mL (90 mg/ 50mg) Administration way: oral

A2: Etoricoxibdrug

Arcoxia®, Schering Plough S.A. de C.V. A2: Pharmaceutical Form: Tablet Formula: 90 mg Dosage: 1 tablet of 90 mg Administration way: oral

A3: Tramadoldrug

Tradol®, from Grünenthal GMBH. Pharmaceutical Form: Capsule Formula: Each capsule contains 50 mg Dosage: 1 capsule of 50 mg Administration way: oral