Clinical trial NCT03684265: A Study to Compare the Amount of Meloxicam in the Blood When it is Taken as Capsules or as Tablets
Official title: An Open-label, Randomised, Single-dose, Two-way Crossover Study in Healthy Male and Female Volunteers to Evaluate the Relative Bioavailability of a New Oral Formulation of Meloxicam, Movalis® Capsules 15 mg, Versus Movalis® Tablets 15 mg, After Administration Under Fasting State.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2018-09-25
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to investigate the relative bioavailability of Movalis capsules 15 mg (Test, T) versus Movalis tablets 15 mg (Reference, R).

The secondary objective of the study is to establish bioequivalence of Movalis capsules 15 mg (Test, T) versus Movalis tablets 15 mg (Reference, R).


Eligibility criteria: Inclusion criteria:

* Male and female subjects aged 18-45, inclusive.
* Body mass index by Quetelet between 18.50 -29.99 kg/m2, inclusive.
* The verified diagnosis is "healthy" according to the conclusion investigator according to the information in the anamnesis, the results of the physical examination, the Electrocardiogram (ECG), the results of measurement of vital signs of the body (blood pressure, heart rate, breathing rate and body temperature), and laboratory indicators.
* Pre-conducting standard clinical and laboratory and instrumental studies did not reveal the presence of any diseases and abnormalities.
* Systolic blood pressure not less than 100 mm Hg. and not higher than 139 mm Hg. diastolic blood pressure not less than 70 mm Hg. and not more than 90 mm Hg. the heart rate is not less than 60 beats per minute and not more than 90 beats per minute, the frequency of respiratory movements is within the range of 12-20 per minute.
* Ability to understand and accept the explanation of the study; the written informed consent of the volunteer to participate in the study in accordance with applicable law.
* Female subjects of childbearing potential who agree on using double-barrier contraception from a screening visit to 30 days after the last administration of the study drug, inclusive. If a female is postmenopausal (no menses for at least 1 year) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) she will be exempt from the requirement. In case of using oral contraceptives, these should be withdrawn at least 2 months before the study.
* Male subjects who agree on using effective contraception (barrier contraceptive methods) from a screening visit to 30 days after the last administration of the study drug, inclusive.

Exclusion criteria:

* Drug intolerance of any drug.
* Allergic history.
* Acute infectious diseases or allergic reactions requiring treatment (including drug allergy), less than 4 weeks before the screening.
* Surgical interventions on the gastrointestinal tract (with the exception of appendectomy), which can have a significant effect on the absorption or metabolism of study drugs.
* Known hypersensitivity to meloxicam or any excipient of the test and reference products.
* Known hypersensitivity to other Non-steroid anti-inflammatory drug (NSAIDs): subjects who have developed signs of asthma, nasal polyps, angio-oedema or urticarial following the administration of acetylsalicylic acid or other NSAIDs.
* Chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine system, as well as diseases of the gastrointestinal tract, liver, kidneys, blood, or other conditions that make it impossible for the volunteer to participate in the study according to the investigator opinion.
* The results of standard laboratory and instrumental methods of examination, obtained during the screening, go beyond normal values.
* History of gastro-intestinal ulceration/ perforation or bleeding; history of malignancy within 5 years before the screening.
* Positive results of blood tests for infections (HIV, syphilis, hepatitis B or C) at screening.
* A positive alcohol test at screening.
* A positive urine drug test (cannabis, benzodiazepines, barbiturates, opiates, cocaine, and amphetamines) at screening.
* Pregnancy or breastfeeding.
* Any diet, for example, vegetarian, for 2 weeks before the first day of screening.
* Alcohol intake more than 10 units. alcohol per week (1 unit of alcohol is equivalent to ½ liter of beer, 200 ml of wine or 50 ml of alcohol) or anamnestic information about alcoholism, drug addiction, abuse of medicines.
* The inability to be without food for at least 12 hours and the inability to take the drug on an empty stomach.
* Blood donation (≥ 450 ml) within 3 months before screening.
* Depot injections, the installation of intrauterine hormonal therapy systems or implants of any drugs for 6 months before the screening;
* For women: use of hormonal contraceptives less than 2 months before the screening.
* Regular drug intake within 2 weeks before the screening.
* Intake of systemic drugs known to alter liver function (barbiturates, omeprazole, cimetidine) within 4 weeks before the screening.
* For women: volunteers with preserved reproductive potential who had unprotected intercourse with an unsterilized male partner for 30 days before the screening
* Participation in another clinical trial within 3 months before the screening.
* Difficult access to the vein, complicating or making it impossible to install a catheter and frequent blood sampling.
* Smoker (≥10 cigarettes or ≥ 3 pipes per day).
* Inability to refrain from smoking on study days.
* Volunteers who do not want or are unable to give up alcohol and excessive physical exertion from the first day of screening and before the visit of follow-up.
* Volunteers who are unwilling or unable to refuse drinks and food containing methylxanthines (coffee, tea, cola, energy drinks, chocolate, etc.) and grapefruit / grapefruit juice, Seville oranges (sour or bitter oranges) and their juices, and dietary supplements and products including St. John's wort (Hypericum perforatum) from the first day of screening and until a follow-up visit.
* Volunteers who lead a lifestyle (including night work and extreme physical activities such as sports or weight lifting), which can make it difficult to interpret the laboratory data obtained during the study.
* Volunteers who do not intend to comply with the study regime.
* Volunteers who are obviously or probably, in the opinion of the investigator, are not able to understand and evaluate the information on this study in the process of signing the ICF, in particular regarding the expected risks and possible discomfort.
* The presence of volunteers dehydration due to diarrhea, vomiting or other cause within the last 24 hours before the first day of screening.
* The presence of volunteers attacks of seizures, epilepsy and any other neurological disorders in the anamnesis
* Recent cerebrovascular bleeding or established systemic bleeding disorders.
* Known lactose intolerance.
* Reports difficulty for swallowing tablets or capsules.

Primary outcomes:
measure: Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-t)
timeFrame: Baseline (pre-dose), 0.5 hours (h), 1.0h, 2.0h, 3.0h, 4.0h, 5.0h, 6.0h, 7.0h, 8.0h, 10.0h, 12.0h, 24.0h, 32.0h, 48.0h and 72.0h post-dose
measure: Maximum Measured Concentration of the Analyte in Plasma (Cmax)
timeFrame: Baseline (pre-dose), 0.5 hours(h), 1.0h, 2.0h, 3.0h, 4.0h, 5.0h, 6.0h, 7.0h, 8.0h, 10.0h, 12.0h, 24.0h, 32.0h, 48.0h and 72.0h post-dose
Secondary outcomes:
measure: Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
timeFrame: Baseline (pre-dose), 0.5 hours(h), 1.0h, 2.0h, 3.0h, 4.0h, 5.0h, 6.0h, 7.0h, 8.0h, 10.0h, 12.0h, 24.0h, 32.0h, 48.0h and 72.0h post-dose
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: City Clinical Hospital named after V.P. Demikhova Department of Health of Moscow
Study officials:
References: