NCT03684265

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

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Meloxicam Capsule (Test)	single dose
DRUG	Meloxicam Tablet (Reference)	single dose

Timeline

• Start date: 2018-10-05
• Primary completion: 2018-10-30
• Completion: 2018-11-06
• First posted: 2018-09-25
• Last updated: 2019-11-22
• Results posted: 2019-11-22

Locations

1 site across 1 country: Russia