At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 26 enrolled
Drug / intervention
Meloxicam Capsule (Test) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 1 clinical trial evaluating Meloxicam Capsule (Test) and Meloxicam Tablet (Reference) for Healthy. Completed, enrolled 26 participants across 1 site.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesRussia
Collaborators--
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
First PostedSep 2018
Enrollment StartOct 2018
Primary CompletionOct 2018
Study CompletionNov 2018
TodayJul 2026
First PostedSep 25, 2018
Enrollment StartOct 5, 2018
Primary CompletionOct 30, 2018
Study CompletionNov 6, 2018
TodayJul 2, 2026
Enrollment to primary: 25 daysPosted 7.8 years ago
Interventions
Meloxicam Capsule (Test)drug
single dose
Meloxicam Tablet (Reference)drug
single dose