NCT05389150

Non-interaction Study Between Pregabalin and Tramadol, Administered Individually or Combination, in Healthy Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Laboratorios Silanes S.A. de C.V. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study design was crossover, 3 x 6 x 3, prospective and longitudinal, at a single dose of the combination Pregabalin 150 mg/Tramadol 50 mg administered orally versus each component administered individually, with three treatments, three periods, six sequences and one elimination period (wash out) of 7 days in 30 healthy subjects, under fasting conditions. The objective of the study was to characterize the pharmacokinetic parameters, maximum plasma concentration (Cmax), area under the curve (AUC), time to achieve Cmax (tmax), elimination constant (Ke), and elimination half life (t1/2) of Pregabalin and Tramadol after single oral dose administration, in combination: Pregabalin 150 mg/Tramadol 50 mg, tablets (Laboratorios Silanes S.A. de C.V.) versus each component individually managed, as well as to establish the frequency and type of events presented after the administration of a single dose of the formulations.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Fixed dose combination Pregabalin 150 mg / Tramadol 50 mg	Pregabalin/Tramadol (Laboratorios Silanes S.A. de C.V.), Pharmaceutical Form: Tablet Dosage: 150 mg / 50 mg Administration way: oral
DRUG	Pregabalin 150mg	From Pfizer S.a. de C.V. Pharmaceutical Form: Capsule Dosage: 150 mg Administration way: oral
DRUG	Tramadol 50 mg	From Grünenthal de México, S.A. de C.V. Pharmaceutical Form: Capsule Dosage: 50 mg Administration way: oral

Timeline

• Start date: 2019-01-17
• Primary completion: 2019-02-05
• Completion: 2019-03-27
• First posted: 2022-05-25
• Last updated: 2024-11-13

Locations

1 site across 1 country: Mexico