PharmacokineticsPhase 1NCT05125588

Fasting Comparative Bioavailability Study of 2 Meloxicam 15 mg Tablets in Healthy Volunteers Under Fasting Condition

A Phase 1 study testing Reumoxicam® 15 mg tablets (PJSC "Farmak", Ukraine) and Movalis 15 mg tablets ("Boehringer Ingelheim Ellas A.E.", Greece) in people with Pharmacokinetics, run by Joint Stock Company "Farmak".

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

The aim of the study was to compare the bioavailability of two formulations of meloxicam given to healthy volunteers and to demonstrate bioequivalence. The test product, Reumoxicam® 15 mg tablets (Farmak PJSC, Ukraine), given in a single dose was compared with a licensed reference product Movalis 15 mg tablets… Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Pharmacokinetics
What is being tested?: Reumoxicam® 15 mg tablets (PJSC "Farmak", Ukraine) and Movalis 15 mg tablets ("Boehringer Ingelheim Ellas A.E.", Greece)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: No sites listed yet
Study dates: 29 Jan 2014to 26 Feb 2014
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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy volunteers, men and women aged 18 to 45 years (inclusive);
Provided written Informed Consent Form of a Healthy Volunteer for Participation in the Clinical Study before the beginning of any screening procedures;
Ability (to the opinion of the investigator) to fulfill all requirements of the Study Protocol, i.e. the volunteer's ability for adequate collaboration;
Body mass index is within the limits (> 18,5 kg/m2 and < 30,0 kg/m2);
Persons free from any acute and chronic diseases of cardiovascular system, neuroendocrine system, kidneys, liver, gastrointestinal tract, and respiratory system;
Results of physical, instrumental, and laboratory examination of volunteers are within the normal limits, or any deviations are classified by the investigator as clinically irrelevant;

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Chest fluorography or radiography results are within the normal limits (the examination should be carried out no earlier than 9 months before the screening moment), or any deviation is classified by the investigator as clinically irrelevant;
Women and men have to use medically confirmed barrier method of contraception during the whole study period;
Volunteers have to be non-smokers or smoke up to 10 cigarettes a day inclusive;
Volunteers need to undertake to follow all general diet limitations during the whole study period.

Who cannot join

Subjects with evidence or suspicion of any relevant clinical abnormality (as based on medical history, physical examination, vital signs, chest X-ray, and 12-lead ECG)
Known hypersensitivity to meloxicam and/or other investigational products ingredients;
Compromised allergologic history;
Subjects who have developed signs of asthma, nasal polyps, angio-oedema or urticaria following the administration of aspirin or other NSAIDs;
Active peptic ulcer, gastrointestinal perforation or bleeding within the last 6 months;
Subjects with peripheral oedema;

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Any previously incurred diseases or surgical interventions which, to the investigator's opinion, may affect pharmacokinetics of the investigational product;
Positive result of HIV, syphilis, hepatitis B and C markets test;
Positive result of urine test for narcotic substances (amphetamine, metamphetamine, morphine, marijuana, cocaine);
Positive result of alcohol vapors test in expired air;
Pregnancy (positive result of urine pregnancy test in women) and lactation period;
Incurred acute infectious diseases within 28 days before beginning of the study;
Use of any medicinal products within 14 days before beginning of the study;
Blood donation or blood loss of more than 300 ml in less than 30 days before beginning of the study;
Participation in any other clinical study during the last 90 days before beginning of the study;
Other reasons which, to the investigator's opinion, make the volunteer's participation in the study undesirable.

About this study

Official title: Randomized, Single-dose, Crossover, Two-period, Two-sequence, Laboratory-blinded, Comparative Bioavailability Study of Meloxicam 15 mg Tablets in Healthy Volunteers Under Fasting Condition.

The secondary objective of the trial was to investigate the safety of both preparations on the basis of safety clinical and laboratory examinations (at the beginning and at the end of the trial) and registration of adverse events and/ or adverse drug reactions.

Read the detailed description

Randomized, single-dose, crossover, two-period, two-sequence, laboratory-blinded, comparative bioavailability study of test medicinal product Reumoxicam® 15 mg tablets (PJSC "Farmak", Ukraine) and reference medicinal product Movalis 15 mg tablets ("Boehringer Ingelheim Ellas A.E.", Greece) in healthy volunteers under fasting condition.

During each period 18 blood samples were taken: before dosing (0) and then at: 0.5; 1; 2; 3; 4; 4.5; 5; 5.5; 6; 7; 8; 10; 12; 24; 36; 48 and 72 hours after dosing.

Conditions: Pharmacokinetics
Being tested: Reumoxicam® 15 mg tablets (PJSC "Farmak", Ukraine), Movalis 15 mg tablets ("Boehringer Ingelheim Ellas A.E.", Greece)
Keywords: bioequivalence, pharmacokinetics, generic drugs, Meloxicam

What participants receive

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

Reumoxicam® 15 mg tablets (PJSC "Farmak", Ukraine)Drug
Also called Meloxicam
One tablet was administered orally and swallowed at once, without chewing, by study volunteers, followed by 200 ml of water, under fasting condition (after preliminary nocturnal fasting for 12 hours) in the morning at 8:00 hours on Day I Period I and Period II of the study.
Movalis 15 mg tablets ("Boehringer Ingelheim Ellas A.E.", Greece)Drug
Also called Meloxicam
One tablet was administered orally and swallowed at once, without chewing, by study volunteers, followed by 200 ml of water, under fasting condition (after preliminary nocturnal fasting for 12 hours) in the morning at 8:00 hours on Day I Period I and Period II of the study.

Study groups in NCT05125588
Study group	Role	What they receive
Treatment A	Experimental	Reumoxicam® 15 mg tablets (PJSC "Farmak", Ukraine) Receives: Drug: Reumoxicam® 15 mg tablets (PJSC "Farmak", Ukraine)
Treatment B	Active comparator	Movalis 15 mg tablets ("Boehringer Ingelheim Ellas A.E.", Greece) Receives: Drug: Movalis 15 mg tablets ("Boehringer Ingelheim Ellas A.E.", Greece)

What is being measured

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

AUC0-t
Area under the plasma concentration-time curve from time zero to time t of the last quantifiable concentration
Measured: up to 72 hours post-administration
Cmax
Maximum drug concentration in plasma
Measured: up to 72 hours post-administration

Secondary outcomes (3)

AUC0-inf
Area under the plasma concentration-time curve from time zero to infinity
Measured: up to 72 hours post-administration
tmax
time after administration to reach maximum drug concentration in plasma
Measured: up to 72 hours post-administration
t1/2
elimination half-life
Measured: up to 72 hours post-administration

Timeline

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

29 Jan 201426 Feb 2014

First posted18 Nov 2021
Study start29 Jan 2014
Primary completion26 Feb 2014
Study completion26 Feb 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PharmacokineticsStudies 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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05125588
Sponsor's protocol ID: FM-MEL
Status last verified: Nov 2021
First submitted: 15 Nov 2021
Last updated: 18 Nov 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Single-dose, Crossover, Two-period, Two-sequence, Laboratory-blinded, Comparative Bioavailability Study of Meloxicam 15 mg Tablets in Healthy Volunteers Under Fasting Condition.
ClinicalTrials.gov ID: NCT05125588
Acronym / sponsor ID: FM-MEL
Conditions: Pharmacokinetics
Keywords: bioequivalence, pharmacokinetics, generic drugs, Meloxicam
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Joint Stock Company "Farmak"Industry (pharma, biotech, devices)
Study start: 29 Jan 2014 (actual)
Primary completion: 26 Feb 2014 (actual)
Study completion: 26 Feb 2014 (actual)
First posted: 18 Nov 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

During each period 18 blood samples were taken: before dosing (0) and then at: 0.5; 1; 2; 3; 4; 4.5; 5; 5.5; 6; 7; 8; 10; 12; 24; 36; 48 and 72 hours after dosing.

Study design

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

Arm	Type	Receives
Treatment A	Experimental	Drug: Reumoxicam® 15 mg tablets (PJSC "Farmak", Ukraine)Reumoxicam® 15 mg tablets (PJSC "Farmak", Ukraine)
Treatment B	Active comparator	Drug: Movalis 15 mg tablets ("Boehringer Ingelheim Ellas A.E.", Greece)Movalis 15 mg tablets ("Boehringer Ingelheim Ellas A.E.", Greece)

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Healthy volunteers, men and women aged 18 to 45 years (inclusive);
Provided written Informed Consent Form of a Healthy Volunteer for Participation in the Clinical Study before the beginning of any screening procedures;
Ability (to the opinion of the investigator) to fulfill all requirements of the Study Protocol, i.e. the volunteer's ability for adequate collaboration;
Body mass index is within the limits (> 18,5 kg/m2 and < 30,0 kg/m2);
Persons free from any acute and chronic diseases of cardiovascular system, neuroendocrine system, kidneys, liver, gastrointestinal tract, and respiratory system;

Key exclusion criteria (16 listed)

Subjects with evidence or suspicion of any relevant clinical abnormality (as based on medical history, physical examination, vital signs, chest X-ray, and 12-lead ECG)
Known hypersensitivity to meloxicam and/or other investigational products ingredients;
Compromised allergologic history;
Subjects who have developed signs of asthma, nasal polyps, angio-oedema or urticaria following the administration of aspirin or other NSAIDs;
Active peptic ulcer, gastrointestinal perforation or bleeding within the last 6 months;

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
Reumoxicam® 15 mg tablets (PJSC "Farmak", Ukraine)Also: MeloxicamOne tablet was administered orally and swallowed at once, without chewing, by study volunteers, followed by 200 ml of water, under fasting condition (after preliminary nocturnal fasting for 12 hours) in the morning at 8:00 hours on Day I Period I and Period II of the study.	Drug	Treatment A
Movalis 15 mg tablets ("Boehringer Ingelheim Ellas A.E.", Greece)Also: MeloxicamOne tablet was administered orally and swallowed at once, without chewing, by study volunteers, followed by 200 ml of water, under fasting condition (after preliminary nocturnal fasting for 12 hours) in the morning at 8:00 hours on Day I Period I and Period II of the study.	Drug	Treatment B

Primary outcome

AUC0-t
Time frame: up to 72 hours post-administration
Area under the plasma concentration-time curve from time zero to time t of the last quantifiable concentration
Cmax
Time frame: up to 72 hours post-administration
Maximum drug concentration in plasma

3 secondary outcomes

AUC0-inf
Time frame: up to 72 hours post-administration
tmax
Time frame: up to 72 hours post-administration
t1/2
Time frame: up to 72 hours post-administration

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 18 Nov 2021.
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.

Vlad Udovytskyi study chair

Joint Stock Company "Farmak"

Questions about this trial

What is this clinical trial studying?

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 10 inclusion and 16 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 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

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?

AUC0-t (time frame: up to 72 hours post-administration). The study lists 2 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 NCT05125588.

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 18 Nov 2021.