Healthy
Conditions
Brief summary
This study seeks to evaluate the comparative bioavailability of etoricoxib/betamethasone tablets 90 mg/0.25 mg test drug, administered in fixed combination vs. etoricoxib tablets 90 mg (Arcoxia®) reference drug, and betamethasone solution 50 mg/100 mL (Celestone® Pediatric) reference drug, administered individually, in a single dose, to 42 healthy mexican research subjects of both genders, under fasting conditions.
Detailed description
The purpose of this study is to determine whether there are differences in the magnitude and rate of absorption between the test drug and the reference drugs. The study will be cross-over, randomized, with three periods, three treatments, six sequences, truncated at 72 hours in 42 healthy subjetcs, with a single dose of etoricoxib/betamethasone 90/0.25 mg tablet administered in combination or a tablet of etoricoxib 90 mg, or betamethasone solution 50 mg/100 mL (Celestone® Pediatric) administered individually under fasting conditions, with 250 mL of water and a 14-day washout period between each dose of the test product.
Interventions
DRUGA1: Etoricoxib / Betamethasone in fixed dose combination tablet. (Laboratorios Silanes S.A. de C.V.)
Formula: 90 mg/ 0.25 mg. Pharmaceutical Form: Tablet. Dosage: 1 tablet (90 mg/ 0.25 mg) Administration way: oral
DRUGA2: Etoricoxib (Arcoxia®, Laboratorios Schering-Plough, S.A. de C.V.)
A2: Pharmaceutical Form: Tablet Formula: 90 mg Dosage: 1 tablet of 90 mg Administration way: oral
DRUGA3: Betamethasone (Celestone® Pediatric, Laboratorios Schering-Plough, S.A. de C.V.)
A3: Pharmaceutical Form: Solution Formula: Each 100 mL of solution contains 50 mg of betamethasone. Dosage: 0.5 mL equivalent to 0.25 mg of betamethasone. Administration way: Oral.
Sponsors
Laboratorios Silanes S.A. de C.V.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the AUC 0-inf | Baseline, 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00, 24.00, 36.00, 48.00 and 72.00 hours. | Evaluate the pharmacokinetics profile of the fixed dose Etoricoxib / Betamethasone employing the area under the curve from time zero to infinity calculated (AUC 0-inf). |
| Determine the Cmax. | Baseline, 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00, 24.00, 36.00, 48.00 and 72.00 hours. | Evaluate the pharmacokinetics profile of the fixed dose Etoricoxib / Betamethasone employing the maximum observed concentration following the treatment (Cmax), obtained graphically, from the plasma concentration profile with respect to time. |
| Determine the AUC 0-t | Baseline, 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00, 24.00, 36.00, 48.00 and 72.00 hours. | Evaluate the pharmacokinetics profile of the fixed dose Etoricoxib / Betamethasone employing the area under the curve from time zero to the last measurable concentration (AUC 0-t) using the linear trapezoidal method. |
| Determine the T1/2 | Baseline, 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00, 24.00, 36.00, 48.00 and 72.00 hours. | Evaluate the pharmacokinetics profile of the fixed dose Etoricoxib / Betamethasone employing the half time elimination (t1/2) by the quotient of Ln(2) Ke. |
| Determine the Tmax | Baseline, 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00, 24.00, 36.00, 48.00 and 72.00 hours. | Evaluate the pharmacokinetics profile of the fixed dose Etoricoxib / Betamethasone employing the time of the maximum measured concentration (tmax) obtained graphically, from the plasma concentration profile with respect to time. |
| Determine the Ke | Baseline, 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00, 24.00, 36.00, 48.00 and 72.00 hours. | Evaluate the pharmacokinetics profile of the fixed dose Etoricoxib / Betamethasone 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
| Measure | Time frame | Description |
|---|---|---|
| Determine the frequency of occurrence of adverse events | 1, 15 and 29 days | The percentage of frequency of appearance of each adverse event was evaluated. |
Countries
Mexico
Contacts
PRINCIPAL_INVESTIGATORLourdes Garza - Ocañas, Dr. med
Department of Pharmacology and Toxicology of the Faculty of Medicine of the Universidad Autónoma de Nuevo León.
Outcome results
None listed