A Study to Compare the Amount of Meloxicam in the Blood When it is Taken as Capsules or as Tablets

NCT03684265 | Completed Phase 1 Results

• 1 other identifier: 0107-0277
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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)

  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). Standard error is actually Geometric standard error.

  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

• Maximum Measured Concentration of the Analyte in Plasma (Cmax)

  Maximum measured concentration of the analyte in plasma (Cmax). Standard error is actually Geometric standard error.

  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 (1)

• Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

  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

Study Arms (2)

Test to Reference

EXPERIMENTAL

Drug: Meloxicam Capsule (Test); Drug: Meloxicam Tablet (Reference)

Reference to Test

EXPERIMENTAL

Drug: Meloxicam Capsule (Test); Drug: Meloxicam Tablet (Reference)

Interventions

Meloxicam Capsule (Test) DRUG

single dose

Also known as: Movalis

Reference to Test; Test to Reference

Meloxicam Tablet (Reference) DRUG

single dose

Also known as: Movalis

Reference to Test; Test to Reference

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

City Clinical Hospital named after V.P. Demikhova Department of Health of Moscow

Moscow, 109263, Russia

Location

MeSH Terms

Interventions

Meloxicam

Intervention Hierarchy (Ancestors)

Thiazines; Sulfur Compounds; Organic Chemicals; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: September 24, 2018
• First Posted: September 25, 2018
• Study Start: October 5, 2018
• Primary Completion: October 30, 2018
• Study Completion: November 6, 2018
• Last Updated: November 22, 2019
• Results First Posted: November 22, 2019

Record last verified: 2019-11

Locations

RU (1)