CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 30 enrolled
Drug / intervention
Fixed dose combination Pregabalin 150 mg / Tramadol 50 mg +2 moredrug
Likely dose
Fixed dose combination Pregabalin 150 mg / Tramadol 50 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/NCT05389150
NCT05389150Phase 1Completed

Pharmacokinetic Non-interaction Study Between Pregabalin 150 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 May 25, 2022·Updated Nov 13, 2024

In Brief

A Phase 1 clinical trial evaluating Fixed dose combination Pregabalin 150 mg / Tramadol 50 mg, Pregabalin 150mg, and 1 other intervention for Healthy. Completed, enrolled 30 participants across 1 site.

Detailed Summary

The study was carried out in the Clinical Unit and Analytical Unit of the Department of Pharmacology and Toxicology of the Faculty of Medicine of the Universidad Autónoma de Nuevo León, with the aim of comparing the bioavailability (maximum concentration and area under the curve) of an oral formulation containing Pregabalin 150 mg/Tramadol 50 mg in combination with the two oral formulations Pregabalin 150 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
20192020202120222023202420252026
First PostedMay 25, 2022
Enrollment StartJan 17, 2019
Primary CompletionFeb 5, 2019
Study CompletionMar 27, 2019
TodayJul 2, 2026
Enrollment to primary: 18 daysPosted 4.1 years ago

Interventions

Fixed dose combination Pregabalin 150 mg / Tramadol 50 mgdrug

Pregabalin/Tramadol (Laboratorios Silanes S.A. de C.V.), Pharmaceutical Form: Tablet Dosage: 150 mg / 50 mg Administration way: oral

Pregabalin 150mgdrug

From Pfizer S.a. de C.V. Pharmaceutical Form: Capsule Dosage: 150 mg Administration way: oral

Tramadol 50 mgdrug

From Grünenthal de México, S.A. de C.V. Pharmaceutical Form: Capsule Dosage: 50 mg Administration way: oral