NCT05125588

Fasting Comparative Bioavailability Study of 2 Meloxicam 15 mg Tablets in Healthy Volunteers Under Fasting Condition

Randomized, Single-dose, Crossover, Two-period, Two-sequence, Laboratory-blinded, Comparative Bioavailability Study of Meloxicam 15 mg Tablets in Healthy Volunteers Under Fasting Condition.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Joint Stock Company "Farmak" · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The aim of the study was to compare the bioavailability of two formulations of meloxicam given to healthy volunteers and to demonstrate bioequivalence. The test product, Reumoxicam® 15 mg tablets (Farmak PJSC, Ukraine), given in a single dose was compared with a licensed reference product Movalis 15 mg tablets ("Boehringer Ingelheim Ellas A.E.", Greece), in a randomized, laboratory-blind, single dose, two periods, crossover study. The secondary objective of the trial was to investigate the safety of both preparations on the basis of safety clinical and laboratory examinations (at the beginning and at the end of the trial) and registration of adverse events and/ or adverse drug reactions.

Detailed description

Randomized, single-dose, crossover, two-period, two-sequence, laboratory-blinded, comparative bioavailability study of test medicinal product Reumoxicam® 15 mg tablets (PJSC "Farmak", Ukraine) and reference medicinal product Movalis 15 mg tablets ("Boehringer Ingelheim Ellas A.E.", Greece) in healthy volunteers under fasting condition. During each period 18 blood samples were taken: before dosing (0) and then at: 0.5; 1; 2; 3; 4; 4.5; 5; 5.5; 6; 7; 8; 10; 12; 24; 36; 48 and 72 hours after dosing.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Reumoxicam® 15 mg tablets (PJSC "Farmak", Ukraine)	One tablet was administered orally and swallowed at once, without chewing, by study volunteers, followed by 200 ml of water, under fasting condition (after preliminary nocturnal fasting for 12 hours) in the morning at 8:00 hours on Day I Period I and Period II of the study.
DRUG	Movalis 15 mg tablets ("Boehringer Ingelheim Ellas A.E.", Greece)	One tablet was administered orally and swallowed at once, without chewing, by study volunteers, followed by 200 ml of water, under fasting condition (after preliminary nocturnal fasting for 12 hours) in the morning at 8:00 hours on Day I Period I and Period II of the study.

Timeline

• Start date: 2014-01-29
• Primary completion: 2014-02-26
• Completion: 2014-02-26
• First posted: 2021-11-18
• Last updated: 2021-11-18