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

NCT ID: NCT05389150

Last Updated: 2024-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-17
• Study Completion Date: 2019-03-27

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A: Pregabalin/ Tramadol Fixed dose

Pharmaceutical Form: Tablet Dosage: 150 mg / 50 mg Administration way: oral

Group Type: EXPERIMENTAL

Fixed dose combination Pregabalin 150 mg / Tramadol 50 mg

Intervention Type: DRUG

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

Group B: Pregabalin (Lyrica®)

Pharmaceutical Form: Capsule Dosage: 150 mg Administration way: oral

Group Type: ACTIVE_COMPARATOR

Pregabalin 150mg

Intervention Type: DRUG

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

Group C: Tramadol (Tradol®)

Pharmaceutical Form: Tablet Dosage: 50 mg Administration way: oral

Group Type: ACTIVE_COMPARATOR

Tramadol 50 mg

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Pregabalin 150mg

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

Intervention Type: DRUG

Tramadol 50 mg

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

Intervention Type: DRUG

Other Intervention Names

P/T; Preg (Lyrica®); Tram (Tradol®)

Eligibility Criteria

Inclusion Criteria

• 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/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 Criteria.
• Research subjects who presents alterations in the vital signs recorded during the selection.
• Subjects who have consumed grapefruit or cranberry juice in the 10 hours prior to the study.
• Research subject with alterations of the vital signs recorded during the selection.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Laboratorios Silanes S.A. de C.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lourdes Garza Ocaña, M.D

Role: PRINCIPAL_INVESTIGATOR

Department of Pharmacology and Toxicology of the Faculty of Medicine of the U.A.N.L

Locations

Laboratorio Silanes, S.A. de C.V.

Mexico City, Mexico City, Mexico

Countries

Mexico

References

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Other Identifiers

BD PT-Sil No. 97-17

Identifier Type: -

Identifier Source: org_study_id