Clinical trial NCT05027126: Comparison of Bioavailability of Dexketoprofen-Vit B vs Dexketoprofen, in Healthy Subjects, Under Fasting Conditions
Official title: Comparison of Bioavailability of Dexketoprofen-Vit B vs Dexketoprofen (Stadium®), Dose 25 mg in Healthy Subjects, of Both Genders, Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Dexketoprofen
Trometamol
Cyanocobalamin
Thiamine
Pyridoxine
Pharmacokinetic
Bioavailability
Fixed-dose combination (FDC)
Bioequivalence
Lead sponsor: Laboratorios Silanes S.A. de C.V.
Sponsor class: INDUSTRY
First posted: 2021-08-30
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Bioavailability comparison study with a cross-over desing, 2x2, open, prospective and longitudinal, at a single dose with two treatments, two periods, two sequences with an elimination (washout) period of 7 days and a number of 36 healthy subjects, of both genders, under fasting conditions, of reference tablets of Dexketoprofen 25 mg (Stadium®), elaborated by Grimann, S.A. de C.V., and capsule test drug with Dexketoprofen 25 mg- Vitamin B complex elaborated by Laboratorios Silanes S.A. de C.V.

Detailed description: The study was designed to recruit 36 healthy subjects considering a 2x2 design, where each subject received both treatments and was its own control. The time was adjusted considering the half-life of the drugs to be evaluated. Healthy subjects of both genders were selected since no relevant pharmacokinetic differences related to gender had been reported for the study drug. The aim of the study was to comparatively evaluate, in the same individuals the plasma concentrations of Dexketoprofen 25 mg from two pharmaceutical formulations; reference tablets of Dexketoprofen 25 mg ( Stadium®), elaborated by Grimann, S.A. de C.V., and capsule test drug with Dexketoprofen 25 mg- Vitamin B complex elaborated by Laboratorios Silanes S.A. de C.V.

Eligibility criteria: Inclusion Criteria:

* That the patient gives informed consent in writing.
* Be accepted by the COFEPRIS research subjects registry base.
* Subjects without subordination relationship with the researchers or sponsor. - Subjects of both genders, aged between 18 and 55, Mexican.
* No history of hypersensitivity or related drug allergies.
* 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 analyzes, carried out in certified clinical laboratories, without alterations that, at the discretion of the Principal Investigator, require medical intervention as a consequence.
* Subjects with negative results for immunological tests (Anti-HIV (Human immunodeficiency virus), Anti-hepatitis B and C, VDRL (venereal disease reaction level)).
* Subjects with negative results in qualitative tests for the detection of drugs of abuse: tetrahydro-cannabinoids, cocaine and
* Research subject that presents alterations in the vital signs recorded during the selection.amphetamines.
* Negative (qualitative) pregnancy test in the case of women of childbearing age without bilateral tubal obstruction or hysterectomy.
* In the case of women of childbearing age, the subject must sign a letter of commitment not to pregnancy and have a birth control method, including barrier methods, non-hormonal intrauterine device or bilateral tubal obstruction.

Exclusion Criteria:

* Subjects with a recent history (3 months) or evidence on physical examination of gastrointestinal, renal, hepatic, endocrine, respiratory, cardiovascular, dermatological or hematological disease that could affect the pharmacokinetic study of the investigational product.
* Subjects who have been exposed to drugs known as liver enzyme inducers or inhibitors or who have taken potentially toxic drugs within 30 days prior to the start of the study.
* Subjects who have received any medication for 7 days prior to the start of the study.
* Subjects who have been hospitalized for any problem during the three months prior to the start of the study.
* Subjects who have been rejected for their registration in the COFEPRIS research subject registry database, 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 60 days prior to the study.
* Subjects allergic to the drug under study or related drugs.
* Subjects who have ingested alcohol or beverages containing xanthines (coffee, tea, cocoa, chocolate, cola soft drinks) or who have ingested charcoal-grilled foods or grapefruit or cranberry juice, at least 10 hours before the start of the study or who have smoked tobacco within 24 hours prior to the start of the internment period.
* Subjects who have donated or lost 450 mL or more of blood within the 60 days prior to the start 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.

Primary outcomes:
measure: Maximum observed concentration following the treatment (Cmax)
timeFrame: Baseline, 0.16, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 14.00 and 24.00 hours
measure: The area under the curve from time zero to the last measurable concentration (AUC 0-t)
timeFrame: Baseline, 0.16, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 14.00 and 24.00 hours
measure: The area under the curve from time zero to infinity calculated (AUC 0-inf)
timeFrame: Baseline, 0.16, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 14.00 and 24.00 hours
measure: Time of the maximum measured concentration (Tmax).
timeFrame: Baseline, 0.16, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 14.00 and 24.00 hours
measure: Elimination rate (Ke)
timeFrame: Baseline, 0.16, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 14.00 and 24.00 hours
measure: Elimination half-life (t 1/2)
timeFrame: Baseline, 0.16, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 14.00 and 24.00 hours
Secondary outcomes:
measure: The frequency of adverse events
timeFrame: 2 days
measure: Adverse events
timeFrame: 2 days
Other outcomes:
Locations:
city: Ciudad de Mexico
country: Mexico
facility: Laboratorio Silanes, S.A. de C.V.
state: Mexico City
Study officials:
affiliation: Department of Pharmacology and Toxicology of the Faculty of Medicine of the U.A.N.L
name: Lourdes Garza Ocaña, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Pharmacology and Toxicology of the Faculty of Medicine of the U.A.N.L
name: Eduardo J Tamez de la O, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barbanoj MJ, Gich I, Artigas R, Tost D, Moros C, Antonijoan RM, Garcia ML, Mauleon D. Pharmacokinetics of Dexketoprofen Trometamol in Healthy Volunteers After Single and Repeated Oral Doses. J Clin Pharmacol. 1998 Dec;38(S1):33S-40S. doi: 10.1002/jcph.1998.38.s1.33.
citation: Barbanoj MJ, Antonijoan RM, Gich I. Clinical pharmacokinetics of dexketoprofen. Clin Pharmacokinet. 2001;40(4):245-62. doi: 10.2165/00003088-200140040-00002.
citation: 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.