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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-28

Study Completion Date

2019-12-02

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A: Dexketoprofen (Stadium®)

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

Group Type ACTIVE_COMPARATOR

Dexketoprofen 25 MG

Intervention Type DRUG

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

Group B: Fixed dose Dexketoprofen-Vitamin B Complex

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

Group Type EXPERIMENTAL

Fixed dose Dexketoprofen-Vitamin B Complex

Intervention Type DRUG

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

Interventions

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Dexketoprofen 25 MG

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

Intervention Type DRUG

Fixed dose Dexketoprofen-Vitamin B Complex

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

Intervention Type DRUG

Other Intervention Names

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(Stadium®) DEXK / VITB

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes