CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 28 enrolled
Drug / intervention
Meloxicam 15 mg Tablets +1 moredrug
Likely dose
Meloxicam 15 mg or Mobic® 15 mg, single-dose, oral, fastingAI-extracted
Key inclusion· 5
  • ✓Non-smoking male or female, age ≥18 years
  • ✓BMI 18.5–29.9 kg/m²
  • ✓Normal physical examination, ECG, and vital signs (BP 100–140/60–90 mmHg, HR 50–99 bpm, temp 35.8–37.5°C)
  • ✓Negative for drugs of abuse, nicotine, alcohol, hepatitis B/C, HIV; females negative for pregnancy
Key exclusion· 9
  • ✕Known hypersensitivity to meloxicam or NSAIDs
  • ✕History of cardiac, pulmonary, GI, endocrine, musculoskeletal, neurological, hematological, or liver disease
  • ✕History or presence of peptic ulcer disease, GI bleeding, or kidney disease
  • ✕Any clinically significant illness in preceding 4 weeks

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00840476
NCT00840476Phase 1Completed
CompareCT.gov

A Two-way Crossover, Open-label, Single-dose, Fasting, Bioequivalence Study of Meloxicam 15 mg Tablets Versus Mobic® 15 mg Tablets in Normal Healthy Non-Smoking Male and Female Subjects

Teva Pharmaceuticals USA·interventional·Posted Feb 10, 2009·Updated Aug 19, 2024

In Brief

A Phase 1 clinical trial evaluating Meloxicam 15 mg Tablets and Mobic® 15 mg Tablets for Healthy. Completed, enrolled 28 participants across 1 site.

Detailed Summary

The objective of this study is to compare the rate and extent of absorption of meloxicam from a test formulation Meloxicam 15 mg Tablets versus the reference Mobic® 15 mg Tablets under fasting conditions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada
Collaborators--

Timeline

Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 10, 2009
Enrollment StartFeb 1, 2004
Primary CompletionFeb 1, 2004
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 17.4 years ago

Interventions

Meloxicam 15 mg Tabletsdrug

1 x 15 mg, single-dose fasting

Mobic® 15 mg Tabletsdrug

1 x 15 mg, single-dose fasting