Comparison of Bioavailability of Dexketoprofen-Vit B vs Dexketoprofen, in Healthy Subjects, Under Fasting Conditions

NCT05027126 | Completed Phase 1

• 1 other identifier: DEXK-Sil No. 101-18
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Dexketoprofen; Trometamol; Cyanocobalamin; Thiamine; Pyridoxine; Pharmacokinetic; Bioavailability; Fixed-dose combination (FDC); Bioequivalence

Outcome Measures

Primary Outcomes (6)

• Maximum observed concentration following the treatment (Cmax)

  Evaluate the fixed dose pharmacokinetics profile of Dexketoprofen-Vitamin B, employing the maximum observed concentration following the treatment (Cmax).

  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

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

  Evaluate the fixed dose pharmacokinetics profile of Dexketoprofen-Vitamin B, 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, 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

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

  Evaluate the fixed dose pharmacokinetics profile of Dexketoprofen-Vitamin B, employing the area under the curve from time zero to infinity (AUC 0-inf), estimated by adding the quotient of the last concentration measured between ke.

  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

• Time of the maximum measured concentration (Tmax).

  Evaluate the fixed dose pharmacokinetics profile of Dexketoprofen-Vitamin B, employing time of the maximum measured concentration (Tmax)

  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

• Elimination rate (Ke)

  Evaluate the fixed dose pharmacokinetics profile of Dexketoprofen-Vitamin B, employing the elimination rate (Ke), calculated by log-linear regression of the final phase of elimination

  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

• Elimination half-life (t 1/2)

  Evaluate the fixed dose pharmacokinetics profile of Dexketoprofen-Vitamin B, employing the elimination half-life (t 1/2) by dividing 0.693 / ke.

  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 (2)

• The frequency of adverse events

  2 days

• Adverse events

  2 days

Study Arms (2)

Group A: Dexketoprofen (Stadium®)

ACTIVE COMPARATOR

Reference Drug Pharmaceutical Form: Tablets Dosage: 25 mg Administration way: oral

Drug: Dexketoprofen 25 MG

Group B: Fixed dose Dexketoprofen-Vitamin B Complex

EXPERIMENTAL

Fixed dose combination: Pharmaceutical Form: capsule Dosage: 25 mg of Dexketoprofen + Cyanocobalamin, Thiamine,and Pyridoxine. Administration way: oral

Drug: Fixed dose Dexketoprofen-Vitamin B Complex

Interventions

Dexketoprofen 25 MG DRUG

Pharmaceutical Form: Tablets Dosage: 25 mg Adminstration way: Oral

Also known as: (Stadium®)

Group A: Dexketoprofen (Stadium®)

Fixed dose Dexketoprofen-Vitamin B Complex DRUG

Pharmaceutical Form: capsule Dosage: 25 mg of Dexketoprofen + Cyanocobalamin 500 µg, Thiamine 100 mg, Pyridoxine 50 mg. Administration way: oral

Also known as: DEXK / VITB

Group B: Fixed dose Dexketoprofen-Vitamin B Complex

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laboratorios Silanes S.A. de C.V.: lead

Study Sites (1)

Laboratorio Silanes, S.A. de C.V.

Mexico City, Mexico City, 11000, Mexico

Location

Related Publications (3)

• 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.

  PMID: 29023869 BACKGROUND

• Barbanoj MJ, Antonijoan RM, Gich I. Clinical pharmacokinetics of dexketoprofen. Clin Pharmacokinet. 2001;40(4):245-62. doi: 10.2165/00003088-200140040-00002.

  PMID: 11368291 BACKGROUND

• 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.

  PMID: 3450848 BACKGROUND

Related Links

• Spanish Agency for Medicines and Health Products (AEMPS). Ministry of Health, Social Policy and Equality. Technical sheet Metamizole ratiopharm 575 mg hard capsules
• STADIUM. Drugs.
• Official Mexican standard that establishes the tests and procedures to demonstrate that a drug is interchangeable. Requirements to which the Authorized Third Parties that carry out the interchangeability tests must be subject.
• R Core Team (2019). R: A language and environment for statistical computing.

MeSH Terms

Interventions

dexketoprofen trometamol

Study Officials

• Lourdes Garza Ocaña, M.D

  Department of Pharmacology and Toxicology of the Faculty of Medicine of the U.A.N.L

  PRINCIPAL INVESTIGATOR

• Eduardo J Tamez de la O, M.D

  Department of Pharmacology and Toxicology of the Faculty of Medicine of the U.A.N.L

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: August 30, 2021
• Study Start: February 28, 2019
• Primary Completion: November 15, 2019
• Study Completion: December 2, 2019
• Last Updated: September 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)