Non-interaction Study Between Pregabalin and Tramadol, Ad... | NCT05389150

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A: Pregabalin/ Tramadol Fixed dose	Experimental	Pharmaceutical Form: Tablet Dosage: 150 mg / 50 mg Administration way: oral	Drug: Fixed dose combination Pregabalin 150 mg / Tramadol 50 mg
Group B: Pregabalin (Lyrica®)	Active Comparator	Pharmaceutical Form: Capsule Dosage: 150 mg Administration way: oral	Drug: Pregabalin 150mg
Group C: Tramadol (Tradol®)	Active Comparator	Pharmaceutical Form: Tablet Dosage: 50 mg Administration way: oral	Drug: Tramadol 50 mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fixed dose combination Pregabalin 150 mg / Tramadol 50 mg	Drug	Pregabalin/Tramadol (Laboratorios Silanes S.A. de C.V.), Pharmaceutical Form: Tablet Dosage: 150 mg / 50 mg Administration way: oral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum observed concentration following the treatment (Cmax)	Evaluate the pharmacokinetics profile of the fixed dose Pregabalin/Tramadol, employing the maximum observed concentration following the treatment (Cmax), obtained graphically, from the plasma concentration profile with respect to time.	Baseline, 0.16, 0.33, 0.50, 1.00, 1.50, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 10.0, 14.0, 24.0 and 36.0 hours.
The area under the curve from time zero to the last measurable concentration (AUC 0-t)	Evaluate the fixed dose pharmacokinetics profile of Pregabalin/Tramadol, employing the area under the curve from time zero to the last measurable concentration (AUC 0-t) using the linear trapezoidal method.	Baseline, 0.16, 0.33, 0.50, 1.00, 1.50, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 10.0, 14.0, 24.0 and 36.0 hours.
The area under the curve from time zero to infinity calculated (AUC 0-inf)	Evaluate the fixed dose pharmacokinetics profile of Pregabalin/Tramadol, employing the area under the curve from time zero to infinity calculated (AUC 0-inf).	Baseline, 0.16, 0.33, 0.50, 1.00, 1.50, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 10.0, 14.0, 24.0 and 36.0 hours.
Time of the maximum measured concentration (Tmax)	Evaluate the fixed dose pharmacokinetics profile of Pregabalin/Tramadol, employing time of the maximum measured concentration (tmax), Obtained graphically, from the plasma concentration profile with respect to time.	Baseline, 0.16, 0.33, 0.50, 1.00, 1.50, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 10.0, 14.0, 24.0 and 36.0 hours.
Elimination rate (Ke)	Evaluate the fixed dose pharmacokinetics profile of Pregabalin/Tramadol, employing the elimination rate (Ke), estimated from the terminal linear portion of the plasma concentration profile with respect to time (on a semi-log scale)

Secondary Outcomes

Measure	Description	Time Frame
Frequency of occurrence of adverse events	The percentage of frequency of appearance of each adverse event was evaluated.	6 and 19 days
Adverse events	Any adverse event were classified by severity, treatment and its relationship with the study drug was evaluated.

Eligibility Module

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.

Name	Affiliation	Role
Lourdes Garza Ocaña, M.D	Department of Pharmacology and Toxicology of the Faculty of Medicine of the U.A.N.L	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Laboratorio Silanes, S.A. de C.V.		Mexico City	Mexico City	11000	Mexico

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19062215	Background	Patel BN, Sharma N, Sanyal M, Shrivastav PS. An accurate, rapid and sensitive determination of tramadol and its active metabolite O-desmethyltramadol in human plasma by LC-MS/MS. J Pharm Biomed Anal. 2009 Feb 20;49(2):354-66. doi: 10.1016/j.jpba.2008.10.030. Epub 2008 Nov 5.
25939332	Background	Filipe A, Almeida S, Pedroso PF, Neves R, Marques S, Sicard E, Massicotte J, Ortuno J. Single-Dose, Randomized, Open-Label, Two-Way, Crossover Bioequivalence Study of Two Formulations of Pregabalin 300 mg Hard Capsules in Healthy Volunteers Under Fasting Conditions. Drugs R D. 2015 Jun;15(2):195-201. doi: 10.1007/s40268-015-0094-8.

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D014147	Tramadol
D000069583	Pregabalin

ID	Term
D003511	Cyclohexanols
D000441	Hexanols
D005233	Fatty Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D004123	Dimethylamines
D008744	Methylamines
D000588	Amines
D008055	Lipids
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates
D002087	Butyrates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins