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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Meloxicam Capsule (Test); Drug: Meloxicam Tablet (Reference)

• Registration Number: NCT03684265
• Lead Sponsor: Boehringer Ingelheim

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-09-24
• Study First Submitted QC: 2018-09-24
• Study First Posted: 2018-09-25
• Study Start: 2018-10-05
• Primary Completion: 2018-10-30
• Study Completion: 2018-11-06
• Status Verified: 2019-11
• Results First Submitted: 2019-11-05
• Results First Submitted QC: 2019-11-05
• Last Update Submitted: 2019-11-05
• Results First Posted: 2019-11-22
• Last Update Posted: 2019-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test to Reference	Meloxicam Tablet (Reference)	-
Reference to Test	Meloxicam Tablet (Reference)	-
Test to Reference	Meloxicam Capsule (Test)	-
Reference to Test	Meloxicam Capsule (Test)	-

Primary Outcome Measures

Name	Time	Method
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)	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	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.
Maximum Measured Concentration of the Analyte in Plasma (Cmax)	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).; Standard error is actually Geometric standard error.

Secondary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

City Clinical Hospital named after V.P. Demikhova Department of Health of Moscow; 🇷🇺 Moscow, Russian Federation