HealthyPhase 1NCT05027126

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

A Phase 1 study testing Dexketoprofen 25 MG and Fixed dose Dexketoprofen-Vitamin B Complex in people with Healthy, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Dexketoprofen 25 MG and Fixed dose Dexketoprofen-Vitamin B Complex
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteMexico
Study dates: 28 Feb 2019to 2 Dec 2019
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

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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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Laboratorio Silanes, S.A. de C.V.
Mexico City, Mexico City, 11000

Other trials in Mexico

About this study

Official title: Comparison of Bioavailability of Dexketoprofen-Vit B vs Dexketoprofen (Stadium®), Dose 25 mg in Healthy Subjects, of Both Genders, Under Fasting Conditions

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.

Read the 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.

Conditions: Healthy
Being tested: Dexketoprofen 25 MG, Fixed dose Dexketoprofen-Vitamin B Complex
Keywords: Dexketoprofen, Trometamol, Cyanocobalamin, Thiamine, Pyridoxine, Pharmacokinetic, Bioavailability, Fixed-dose combination (FDC), Bioequivalence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dexketoprofen 25 MGDrug
Also called (Stadium®)
Pharmaceutical Form: Tablets Dosage: 25 mg Adminstration way: Oral
Fixed dose Dexketoprofen-Vitamin B ComplexDrug
Also called DEXK / VITB
Pharmaceutical Form: capsule Dosage: 25 mg of Dexketoprofen + Cyanocobalamin 500 µg, Thiamine 100 mg, Pyridoxine 50 mg. Administration way: oral

Study groups in NCT05027126
Study group	Role	What they receive
Group A: Dexketoprofen (Stadium®)	Active comparator	Reference Drug Pharmaceutical Form: Tablets Dosage: 25 mg Administration way: oral Receives: 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 Receives: Drug: Fixed dose Dexketoprofen-Vitamin B Complex

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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
The percentage of frequency of appearance of each adverse event was evaluated.
Measured: 2 days
Adverse events
Any adverse event were classified by severity, treatment and its relationship with the study drug was evaluated.
Measured: 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Feb 20192 Dec 2019

First posted30 Aug 2021
Study start28 Feb 2019
Primary completion15 Nov 2019
Study completion2 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05027126
Sponsor's protocol ID: DEXK-Sil No. 101-18
Status last verified: Aug 2021
First submitted: 25 Aug 2021
Last updated: 5 Sep 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 29023869
Barbanoj MJ, Antonijoan RM, Gich I. Clinical pharmacokinetics of dexketoprofen. Clin Pharmacokinet. 2001;40(4):245-62. doi: 10.2165/00003088-200140040-00002.
PubMed 11368291
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Bioavailability of Dexketoprofen-Vit B vs Dexketoprofen (Stadium®), Dose 25 mg in Healthy Subjects, of Both Genders, Under Fasting Conditions
ClinicalTrials.gov ID: NCT05027126
Acronym / sponsor ID: DEXK-Sil No. 101-18
Conditions: Healthy
Keywords: Dexketoprofen, Trometamol, Cyanocobalamin, Thiamine, Pyridoxine, Pharmacokinetic, Bioavailability, Fixed-dose combination (FDC)
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Laboratorios Silanes S.A. de C.V.Industry (pharma, biotech, devices)
Study start: 28 Feb 2019 (actual)
Primary completion: 15 Nov 2019 (actual)
Study completion: 2 Dec 2019 (actual)
First posted: 30 Aug 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group A: Dexketoprofen (Stadium®)	Active comparator	Drug: Dexketoprofen 25 MGReference Drug Pharmaceutical Form: Tablets Dosage: 25 mg Administration way: oral
Group B: Fixed dose Dexketoprofen-Vitamin B Complex	Experimental	Drug: Fixed dose Dexketoprofen-Vitamin B ComplexFixed dose combination: Pharmaceutical Form: capsule Dosage: 25 mg of Dexketoprofen + Cyanocobalamin, Thiamine,and Pyridoxine. Administration way: oral

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

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

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dexketoprofen 25 MGAlso: (Stadium®)Pharmaceutical Form: Tablets Dosage: 25 mg Adminstration way: Oral	Drug	Group A: Dexketoprofen (Stadium®)
Fixed dose Dexketoprofen-Vitamin B ComplexAlso: DEXK / VITBPharmaceutical Form: capsule Dosage: 25 mg of Dexketoprofen + Cyanocobalamin 500 µg, Thiamine 100 mg, Pyridoxine 50 mg. Administration way: oral	Drug	Group B: Fixed dose Dexketoprofen-Vitamin B Complex

Primary outcome

Maximum observed concentration following the treatment (Cmax)
Time frame: 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
Evaluate the fixed dose pharmacokinetics profile of Dexketoprofen-Vitamin B, employing the maximum observed concentration following the treatment (Cmax).
The area under the curve from time zero to the last measurable concentration (AUC 0-t)
Time frame: 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
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.
The area under the curve from time zero to infinity calculated (AUC 0-inf)
Time frame: 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
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.
Time of the maximum measured concentration (Tmax).
Time frame: 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
Evaluate the fixed dose pharmacokinetics profile of Dexketoprofen-Vitamin B, employing time of the maximum measured concentration (Tmax)
Elimination rate (Ke)
Time frame: 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
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
Elimination half-life (t 1/2)
Time frame: 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
Evaluate the fixed dose pharmacokinetics profile of Dexketoprofen-Vitamin B, employing the elimination half-life (t 1/2) by dividing 0.693 / ke.

2 secondary outcomes

The frequency of adverse events
Time frame: 2 days
Adverse events
Time frame: 2 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
Background: PubMed 29023869Barbanoj 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.
Background: PubMed 11368291Barbanoj MJ, Antonijoan RM, Gich I. Clinical pharmacokinetics of dexketoprofen. Clin Pharmacokinet. 2001;40(4):245-62. doi: 10.2165/00003088-200140040-00002.
Background: PubMed 3450848Schuirmann 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.
Spanish Agency for Medicines and Health Products (AEMPS). Ministry of Health, Social Policy and Equality. Technical sheet Metamizole ratiopharm 575 mg hard capsulesLink provided by the sponsor.
STADIUM. Drugs.Link provided by the sponsor.
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.Link provided by the sponsor.
R Core Team (2019). R: A language and environment for statistical computing.Link provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lourdes Garza Ocaña, M.D principal investigator

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

Eduardo J Tamez de la O, M.D principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dexketoprofen 25 MG and Fixed dose Dexketoprofen-Vitamin B Complex in people with Healthy, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum observed concentration following the treatment (Cmax) (time frame: 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 study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05027126, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.