CClinicalTrials.gg
Sign In
CompletedNCT05533073Updated Sep 9, 2022

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

A Phase 1 interventional study of A1: Etoricoxib / Tramadol Fixed dose combination and A2: Etoricoxib in Healthy, sponsored by Laboratorios Silanes S.A. de C.V.. Completed at 1 site in Mexico. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-09.

Sponsored by Laboratorios Silanes S.A. de C.V. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Aug 2020, registered Sep 2022).
Phase
Phase 1
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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.

Read the detailed 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).

02

Conditions studied

  • Healthy

Keywords

  • Pharmacokinetic
  • Bioavailability
  • Fixed-dose combination (FDC)
  • Etoricoxib
  • Tramadol
  • Pain
03

In context

Lead sponsor

Laboratorios Silanes S.A. de C.V. is the lead sponsor of 43 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    Group A: Etoricoxib/Tramadol FDC

    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

    Drug: A1: Etoricoxib / Tramadol Fixed dose combination

  • Active comparator
    Group B: Etoricoxib

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

    Drug: A2: Etoricoxib

  • Active comparator
    Group C: Tramadol

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

    Drug: A3: Tramadol

Interventions

  • DrugA1: Etoricoxib / Tramadol Fixed dose combination

    Sachet with granules (Laboratorios Silanes S.A. de C.V.). Formula : 90 mg/ 50 mg Pharmaceutical Form: Sachet with granules Dosage: 100 mL (90 mg/ 50mg) Administration way: oral

    Also known as: E/T

  • DrugA2: Etoricoxib

    Arcoxia®, Schering Plough S.A. de C.V. A2: Pharmaceutical Form: Tablet Formula: 90 mg Dosage: 1 tablet of 90 mg Administration way: oral

    Also known as: Arcoxia®

  • DrugA3: Tramadol

    Tradol®, from Grünenthal GMBH. Pharmaceutical Form: Capsule Formula: Each capsule contains 50 mg Dosage: 1 capsule of 50 mg Administration way: oral

    Also known as: Tradol®

06

What researchers measure

Primary outcomes

  1. Maximum observed concentration following the treatment (Cmax)

    Evaluate the pharmacokinetics profile of the fixed dose Etoricoxib/Tramadol, employing the maximum observed concentration following the treatment (Cmax), obtained graphically, from the plasma concentration profile with respect to time.

    Time frame: Baseline, 0.25, 0.50, 0.75, 1.00, 1.50, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12,0, 15.0, 24.0, 30.0, 36.0, 48.0 and 72.0 hours.

  2. The area under the curve from time zero to the last measurable concentration (AUC 0-t)

    Evaluate the fixed dose pharmacokinetics profile of Etoricoxib/Tramadol, employing the area under the curve from time zero to the last measurable concentration (AUC 0-t) using the linear trapezoidal method.

    Time frame: Baseline, 0.25, 0.50, 0.75, 1.00, 1.50, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12,0, 15.0, 24.0, 30.0, 36.0, 48.0 and 72.0 hours.

  3. The area under the curve from time zero to infinity calculated (AUC 0-inf),

    Evaluate the fixed dose pharmacokinetics profile of Etoricoxib/Tramadol, employing the area under the curve from time zero to infinity calculated (AUC 0-inf).

    Time frame: Baseline, 0.25, 0.50, 0.75, 1.00, 1.50, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12,0, 15.0, 24.0, 30.0, 36.0, 48.0 and 72.0 hours.

  4. Time of the maximum measured concentration (Tmax).

    Evaluate the fixed dose pharmacokinetics profile of Etoricoxib/Tramadol, employing time of the maximum measured concentration (tmax), Obtained graphically, from the plasma concentration profile with respect to time.

    Time frame: Baseline, 0.25, 0.50, 0.75, 1.00, 1.50, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12,0, 15.0, 24.0, 30.0, 36.0, 48.0 and 72.0 hours.

  5. Elimination rate (Ke)

    Evaluate the fixed dose pharmacokinetics profile of Etoricoxib/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)

    Time frame: Baseline, 0.25, 0.50, 0.75, 1.00, 1.50, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12,0, 15.0, 24.0, 30.0, 36.0, 48.0 and 72.0 hours.

  6. Half time elimination (t1/2)

    Evaluate the pharmacokinetics profile of the fixed dose Etoricoxib/Tramadol, employing the half time elimination (t1/2) by the quotient of Ln(2)Ke.

    Time frame: Baseline, 0.25, 0.50, 0.75, 1.00, 1.50, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12,0, 15.0, 24.0, 30.0, 36.0, 48.0 and 72.0 hours.

Secondary outcomes

  1. Determine the frequency of occurrence of adverse events

    The percentage of frequency of appearance of each adverse event was evaluated.

    Time frame: 1, 15 and 29 days

  2. Adverse Events

    Any adverse event were classified by severity, treatment and its relationship with the study drug was evaluated.

    Time frame: 1, 15 and 29 days

07

Study locations

1 site
  • Laboratorio Silanes, S.A. de C.V.
    Mexico City, 11000, Mexico
08

References and documents

Publications

  • Rosenthal R. An application of the Kolmogorov-Smirnov test for normality with estimated mean and variance. Psychol Rep. 1968 Apr;22(2):570. doi: 10.2466/pr0.1968.22.2.570. No abstract available. PubMed 5650254 ↗
  • Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419. PubMed 3450848 ↗
  • Hauck WW, Anderson S. A new statistical procedure for testing equivalence in two-group comparative bioavailability trials. J Pharmacokinet Biopharm. 1984 Feb;12(1):83-91. doi: 10.1007/BF01063612. PubMed 6747820 ↗
  • Shohag MH, Islam MS, Ahmed MU, Joti JJ, Islam MS, Hasanuzzaman M, Hasnat A. Pharmacokinetic and bioequivalence study of etoricoxib tablet in healthy Bangladeshi volunteers. Arzneimittelforschung. 2011;61(11):617-21. doi: 10.1055/s-0031-1300564. PubMed 22232850 ↗
  • Agrawal NG, Porras AG, Matthews CZ, Rose MJ, Woolf EJ, Musser BJ, Dynder AL, Mazina KE, Lasseter KC, Hunt TL, Schwartz JI, McCrea JB, Gottesdiener KM. Single- and multiple-dose pharmacokinetics of etoricoxib, a selective inhibitor of cyclooxygenase-2, in man. J Clin Pharmacol. 2003 Mar;43(3):268-76. doi: 10.1177/0091270003251122. PubMed 12638395 ↗
  • Silva Mde F, Schramm SG, Kano EK, Mori Koono EE, Porta V, dos Reis Serra CH. Bioequivalence evaluation of single doses of two tramadol formulations: a randomized, open-label, two-period crossover study in healthy Brazilian volunteers. Clin Ther. 2010 Apr;32(4):758-65. doi: 10.1016/j.clinthera.2010.03.016. PubMed 20435245 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05533073
Lead sponsor
Laboratorios Silanes S.A. de C.V.
Responsible party
Sponsor
First posted
Sep 8, 2022
Start date
Aug 3, 2020
Primary completion
Sep 7, 2020
Completion
Nov 30, 2020
Last update
Sep 9, 2022

Study contacts

Lourdes Garza Ocaña, M.D
principal investigator · Department of Pharmacology and Toxicology of the Faculty of Medicine of the U.A.N.L

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Laboratorios Silanes S.A. de C.V.

Start the discussion