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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test to Reference | Experimental |
| |
| Reference to Test | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meloxicam Capsule (Test) | Drug | single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). 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 |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City Clinical Hospital named after V.P. Demikhova Department of Health of Moscow | Moscow | 109263 | Russia |
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). Requestors can use the following link http:// trials.boehringer-ingelheim.com/ to:
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All subjects were screened for eligibility to participate in trial. Subjects attended specialist site to ensure that they (the subjects) met all implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial drug if any of the specific entry criteria was violated. In this study, 26 subjects were entered & treated.
The trial was a randomised, two-period, two sequences, single-dose, open-label, and crossover trial in healthy male and female subjects in fasting conditions.
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| ID | Title | Description |
|---|---|---|
| FG000 | Movalis® Capsules (T), Then Movalis® Tablets (R) | Patient were orally administered single dose of Movalis® capsules 15 mg (T) with 200 mL of water after an overnight fast of at least 10 hours (h) in Period 1, followed with single dose of Movalis® tablets 15 mg (R) with 200 mL of water after an overnight fast of at least 10 h in Period 2. The washout period between two drug administrations was of 7 days. |
| FG001 | Movalis® Tablets (R), Then Movalis® Capsules (T) | Patient were orally administered single dose of Movalis® tablets 15 mg (R) with 200 mL of water after an overnight fast of at least 10 h in Period 1, followed with single dose of Movalis® capsules 15 mg (T) with 200 mL of water after an overnight fast of at least 10 h in Period 2. The washout period between two drug administrations was of 7 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
| |||||||||||||
| Washout Period of 1 Week |
| |||||||||||||
| Treatment Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Movalis® Capsules (T), Then Movalis® Tablets (R) | Patient were orally administered single dose of Movalis® capsules 15 mg (T) with 200 mL of water after an overnight fast of at least 10 hours (h) in Period 1, followed with single dose of Movalis® tablets 15 mg (R) with 200 mL of water after an overnight fast of at least 10 h in Period 2. The washout period between two drug administrations was of 7 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Pharmacokinetic set (PKS): This set includes all randomised subjects who met the protocol requirements without important protocol deviation and completed all study periods. | Posted | Geometric Least Squares Mean | Standard Error | Nanogram (ng)·hour (h)/ mililiter(mL) | 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 |
|
From first drug administration until 7 days after the last drug administration, ie., up to 8 days.
There were no Serious Adverse Event (SAE), Death and other Adverse Event (AE) (with frequency threshold of 5%) were reported for this tiral.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Movalis® Capsules (T) | Patient were orally administered single dose of Movalis® capsules 15 mg (T) with 200 mL of water after an overnight fast of at least 10 h. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 28, 2018 | Nov 4, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 6, 2019 | Nov 4, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000077239 | Meloxicam |
| ID | Term |
|---|---|
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D013844 | Thiazoles |
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| Meloxicam Tablet (Reference) | Drug | single dose |
|
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Movalis® Tablets (R), Then Movalis® Capsules (T) | Patient were orally administered single dose of Movalis® tablets 15 mg (R) with 200 mL of water after an overnight fast of at least 10 h in Period 1, followed with single dose of Movalis® capsules 15 mg (T) with 200 mL of water after an overnight fast of at least 10 h in Period 2. The washout period between two drug administrations was of 7 days. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | All subjects were Caucasian. Ethnicity were not collected from any participant | Number | Paticipants |
|
| OG001 | Movalis® Tablets (R) | Patient were orally administered single dose of Movalis® tablets 15 mg (R) with 200 mL of water after an overnight fast of at least 10 h. |
|
|
|
| Primary | 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. | PKS | Posted | Geometric Least Squares Mean | Standard Error | ng/mL | 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 | Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Standard error is actually Geometric standard error. | PKS | Posted | Geometric Least Squares Mean | Standard Error | ng·h/mL | 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 |
|
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Movalis® Tablets (R) | Patient were orally administered single dose of Movalis® tablets 15 mg (R) with 200 mL of water after an overnight fast of at least 10 h. | 0 | 26 | 0 | 26 | 0 | 26 |
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Bioequivalence acceptance range for the ratio of geometric means was 80- 125%
Bioequivalence acceptance range for the ratio of geometric means was 80- 125%