Comparative Bioavailability Study Between Etoricoxib and Tramadol, Administered Individually or in Combination

Laboratorios Silanes

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: A3: Tramadol

Drug: A1: Etoricoxib / Tramadol Fixed dose combination

Drug: A2: Etoricoxib

Study type

Interventional

Funder types

Industry

Identifiers

NCT05533073

BD ET-Sil No. 112-19

Details and patient eligibility

About

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.

Full description

The study design was a crossover, 3 x 6 x 3, open-label, prospective and longitudinal, truncated, single-dose combination of Etoricoxib 90 mg / Tramadol 50 mg administered orally versus each component administered individually, with three treatments, three periods. , six sequences with an elimination period (washout) of 14 days and with a total of 42 healthy subjects, of both genders, under fasting conditions. Among the objectives were the characterization of the pharmacokinetic parameters, Cmax, AUC 0-72, Tmax, Ke and T1/2 of Etoricoxib and Tramadol after oral administration in a single dose, in combination: sachet with granules equivalent to Etoricoxib 90 mg/ Tramadol 50 mg manufactured by Laboratorios Silanes, S.A. of C.V. versus each component administered individually: Etoricoxib 90 mg tablet (Arcoxia®) manufactured by Schering Plough S.A de C.V. and Tramadol 50 mg capsule (Tradol®) made by Grunenthal GMBH (private company).

Enrollment

42 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

The subjects must have been accepted by the COFEPRIS (Federal Commission for the Protection against Sanitary Risks) 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/m2.
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.

Exclusion criteria

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 (Diagnostic and Statistical Manual of Mental Disorders) Criteria.
Research subjects who presents alterations in the vital signs recorded during the selection.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

42 participants in 3 patient groups

Group A: Etoricoxib/Tramadol FDC

Experimental group

Description:

Pharmaceutical Form: Sachet with granules to dilute in 100 mL of water Formula: Each sachet contains Etoricoxib 90 mg / Tramadol 50 mg Dosage: 100 mL Administration way: oral

Treatment:

Drug: A1: Etoricoxib / Tramadol Fixed dose combination

Group B: Etoricoxib

Active Comparator group

Description:

Pharmaceutical Form: Tablet Formula: Tablet containing Etoricoxib 90 mg Dosage: 1 tablet of 90 mg Administration way: oral

Treatment:

Drug: A2: Etoricoxib

Group C: Tramadol

Active Comparator group

Description:

Pharmaceutical Form: Capsule Formula: Each capsule contains 50mg of Tramadol Dosage:1 capsule of 50 mg Administration way: oral