Status:
COMPLETED
Non-interaction Study Between Pregabalin and Tramadol, Administered Individually or Combination, in Healthy Subjects
Lead Sponsor:
Laboratorios Silanes S.A. de C.V.
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 o...
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 ind...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05389150
Start Date
January 17 2019
End Date
March 27 2019
Last Update
November 13 2024
Active Locations (1)
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1
Laboratorio Silanes, S.A. de C.V.
Mexico City, Mexico City, Mexico, 11000