2004•Chinese New Drugs JournalRequires access

Study on the pharmacokinetics and relative bioavailability of meloxicam preparations in healthy volunteers

Chen Hui

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Abstract

Objective:To study the pharmacokinetics and relative bioavailability of meloxicam preparations including capsules and tablets. Methods: In the randomized crossover study, 18 healthy male volunteers were divided to receive a single oral dose of 15 mg domestic meloxicam capsule, domestic meloxicam tablets or imported meloxicam tablets and the blood drug levels were measured by RP-HPLC. Results:For domestic tablets, domestic capsules and imported tablets, the Cmax were (2. 28±0.29),(2.01± 0.33) and (2.04±0.47)μg·L-1 respectively, the Tmax were (4.67± 2.85), (4.78±3.21) and (5. 78±2.96)h respectively; the t1/2 were (26. 11±12. 21), (25. 77±11. 22) and (28.27±12.99)h respectively; AUC0-∞were (87. 09±38. 76), (82. 10±29.56) and (83.60±33.09)μg· h·L-1 respectively. The relative bioavailability were (106. 2±21. 1) % for domestic capsules and tablets, and (102. 6±22. 8)% for imported tablets. Conclusion: Results analysis indicated that domestic capsules, domestic tablets and the imported tablets were bioequivalent.

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Objective:To study the pharmacokinetics and relative bioavailability of meloxicam preparations including capsules and tablets. Methods: In the randomized crossover study, 18 healthy male volunteers were divided to receive a single oral dose of 15 mg domestic meloxicam capsule, domestic meloxicam tablets or imported meloxicam tablets and the blood drug levels were measured by RP-HPLC. Results:For domestic tablets, domestic capsules and imported tablets, the Cmax were (2. 28±0.29),(2.01± 0.33) and (2.04±0.47)μg·L-1 respectively, the Tmax were (4.67± 2.85), (4.78±3.21) and (5. 78±2.96)h respectively; the t1/2 were (26. 11±12. 21), (25. 77±11. 22) and (28.27±12.99)h respectively; AUC0-∞were (87. 09±38. 76), (82. 10±29.56) and (83.60±33.09)μg· h·L-1 respectively. The relative bioavailability were (106. 2±21. 1) % for domestic capsules and tablets, and (102. 6±22. 8)% for imported tablets. Conclusion: Results analysis indicated that domestic capsules, domestic tablets and the imported tablets were bioequivalent.

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Available abstract

Objective:To study the pharmacokinetics and relative bioavailability of meloxicam preparations including capsules and tablets. Methods: In the randomized crossover study, 18 healthy male volunteers were divided to receive a single oral dose of 15 mg domestic meloxicam capsule, domestic meloxicam tablets or imported meloxicam tablets and the blood drug levels were measured by RP-HPLC. Results:For domestic tablets, domestic capsules and imported tablets, the Cmax were (2. 28±0.29),(2.01± 0.33) and (2.04±0.47)μg·L-1 respectively, the Tmax were (4.67± 2.85), (4.78±3.21) and (5. 78±2.96)h respectively; the t1/2 were (26. 11±12. 21), (25. 77±11. 22) and (28.27±12.99)h respectively; AUC0-∞were (87. 09±38. 76), (82. 10±29.56) and (83.60±33.09)μg· h·L-1 respectively. The relative bioavailability were (106. 2±21. 1) % for domestic capsules and tablets, and (102. 6±22. 8)% for imported tablets. Conclusion: Results analysis indicated that domestic capsules, domestic tablets and the imported tablets were bioequivalent.

Key concepts: Meloxicam, Bioequivalence, Bioavailability, Cmax, Pharmacokinetics, Crossover study, Medicine, Pharmacology

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