Bioequivalence evaluation of two brands of meloxicam tablets (Promotion® and Mobicox®): Pharmacokinetics in a healthy female Mexican population

Biopharmaceutics and Drug Disposition

Volumn 26, Issue 5, 2005, Pages 167-171

  Marcelín Jiménez, Gab ^a   Hernández, José A ^a   Ángeles, Alionka P ^a   Contreras, L ^a   Garcia A ^a   Hinojosa, M ^a   Morales, M ^a   Rivera, L ^a   Martinez Rossier L ^a   Fernandez A ^a  

^a HOSPITAL GENERAL DE MÉXICO   (Mexico)

Author keywords

Bioequivalence; High performance liquid chromatography (HPLC); Meloxicam; Pharmacokinetics

Indexed keywords

MELOXICAM; MOBICOX; PROMOTION;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG HALF LIFE; FEMALE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN EXPERIMENT; MEXICO; NORMAL HUMAN; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; TABLET FORMULATION; VOLUNTEER;

ADMINISTRATION, ORAL; ADULT; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; CROSS-OVER STUDIES; FEMALE; HALF-LIFE; HUMANS; MIDDLE AGED; TABLETS; THERAPEUTIC EQUIVALENCY; THIAZINES; THIAZOLES;

EID: 22144467317     PISSN: 01422782     EISSN: None     Source Type: Journal    
DOI: 10.1002/bdd.446     Document Type: Article

References (15)

1. Pairet M, van Ryn J. Experimental models used to investigate the differential inhibition of cyclooxygenase-1 and cyclooxygenase-2 by non-steroidal anti-inflammatory drugs. Inflamm Res 1998; 47(Suppl 2): S93-S101.
2. Engelhardt G, Homma D, Schlegel K. Anti-inflammatory, analgesic, anti-pyretic and related properties of meloxicam, a new non-steroidal anti-inflammatory agent with favourable gastrointestinal tolerance. Inflamm Res 1995; 44: 423-433.
3. Türck D, Busch U, Heinzel G. Clinical pharmacokinetics of meloxicam. Arzneimittel Forschung 1997; 47: 253-258.
4. Busch U, Heinzel G, Narjes H. Effect of food on pharmacokinetics of meloxicam, a new non-steroidal anti-inflammatory drug (NSAID). Agents Actions 1991; 32: 52-53.
5. Degner F, Heinzel G, Busch U. Transsynovial kinetics of meloxicam. Scand J Rheumatol 1994; S98: A121.
6. Schmid J, Busch U, Heinzel G. Pharmacokinetics and metabolic pattern after intravenous infusion and oral administration of meloxicam to healthy subjects. Drug Metab Dispos 1995; 23: 1206-1213.
7. Davies NM, Skjodt NM. Clinical pharmacokinetics of meloxicam. A cyclo-oxygenase-2 preferential NSAID. Clin Pharmacokinet 1999; 36: 115-126.
8. Velpandian T, Jaiswal J, Bhardwaj RK, Gupta SK. Development and validation of a new HPLC estimation method of meloxicam in biological samples. J Chromatogr B 2000; 738: 431-436.
9. Secretaría de Salud. Pruebas y procedimientos para demostrar intercambiabilidad de formulaciones farmacéuticas. NOM-177-SSA1-1998, Secretaría de Salud, México.
10. Pharshigt Corporation. WINNONLIN, version 3.1 software. Pharshigt Corporation, CA, USA, 2000.
11. FDA (CDER). Guidance for Industry. Statistical Approaches to Establishing Bioequivalence. FDA (CDER). US Department of Health and Human Services, USA, January 2001.
12. Busch U, Heinzel G, Narjes H. Pharmacokinetics of meloxicam in patients with liver insufficiency associated with liver cirrhosis. Rheumatol Eur 1995; 24: 177.
13. Boulton-Jones JM, Geddes CG, Heinzel G. Meloxicam pharmacokinetics in renal impairment. Br J Clin Pharmacol 1997; 43: 35-40.
14. Sander O, Hübner G, Türck D. Meloxicam pharmacokinetics in elderly compared to younger male and female patients with rheumatoid arthritis. Rheumatol Eur 1995; 24: 221.
15. Insel PA. Analgesic-antipyretic and anti-inflammatory agents and drugs employed in the treatment of gout. In The Pharmacological Basis of Therapeutics, Goodman, Gilman (eds). McGraw-Hill International: New York, 1996; 617-657.