PMID- 20206793
OWN - NLM
STAT- MEDLINE
DCOM- 20100528
LR  - 20131121
IS  - 1879-114X (Electronic)
IS  - 0149-2918 (Linking)
VI  - 32
IP  - 2
DP  - 2010 Feb
TI  - Relative bioavailability of two oral formulations of piroxicam 20 mg: a 
      single-dose, randomized-sequence, open-label, two-period crossover comparison in 
      healthy Mexican adult volunteers.
PG  - 357-64
LID - 10.1016/j.clinthera.2010.02.002 [doi]
AB  - BACKGROUND: Piroxicam is an NSAID indicated for the treatment of rheumatoid 
      diseases. Although there are generic formulations of oral piroxicam marketed in 
      Mexico, a literature search did not identify published data concerning the 
      bioavailability of these formulations in the Mexican population. OBJECTIVES: The 
      aims of this study were to determine the bioequivalence of a generic (test) and a 
      reference formulation of oral piroxicam 20 mg and to generate data regarding the 
      oral bioavailability of this drug in a Mexican population. METHODS: This 
      single-dose, randomized-sequence, open-label, 2-period crossover study was 
      conducted in healthy Mexican adult volunteers. Subjects were randomly assigned to 
      receive the test formulation followed by the reference formulation, or vice 
      versa, with a 15-day washout period between doses. Study drugs were administered 
      after a 10-hour overnight fast. For pharmacokinetic analysis, blood samples were 
      drawn at 0 (baseline), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 
      120, and 168 hours after administration. Plasma concentrations of piroxicam were 
      determined using HPLC. The test and reference formulations were to be considered 
      bioequivalent if the 90% CIs for the geometric mean test/reference ratios were 
      within a predetermined range of 80% to 125%. Tolerability was determined using 
      clinical assessment, monitoring of vital signs, laboratory analysis, and subject 
      interviews regarding adverse events (AEs). RESULTS: A total of 28 subjects were 
      enrolled (15 men, 13 women; mean [SD] age, 24 [4] years [range, 19-35 years]; 
      weight, 63.0 [8.9] kg [range, 47.5-81.9 kg]; height, 165 [10] cm [range, 149-179 
      cm]; and body mass index, 23.2 [1.4] kg/m(2) [range, 20.6-26.0 kg/m(2)]). The 90% 
      CIs for piroxicam C(max), AUC(0-infinity), and AUC(0-infinity)) were 89.98% to 
      101.04%, 91.46% to 101.19%, and 93.51% to 105.86%, respectively. Thirteen 
      subjects reported a total of 17 AEs during the study. None of the AEs were 
      considered serious or related to the administered formulations. The most common 
      AE was local postvenipuncture ecchymosis, reported in 8 subjects (28.6%). 
      CONCLUSIONS: In this small study in healthy Mexican adult subjects, a single 
      20-mg dose of the test formulation of orally administered piroxicam met the 
      regulatory requirements to assume bioequivalence, based on the rate and extent of 
      absorption. Both formulations were well tolerated. Mexican national registry 
      code: CE-PEC.0875.
CI  - Copyright 2010. Published by EM Inc USA.
FAU - Palma-Aguirre, Jose Antonio
AU  - Palma-Aguirre JA
AD  - Centro de Estudios Cientificos y Clinicos Pharma, S.A. de C.V., Mexico City, 
      Mexico.
FAU - Lopez-Gamboa, Mireya
AU  - Lopez-Gamboa M
FAU - Carino, Lizbeth
AU  - Carino L
FAU - Burke-Fraga, Victoria
AU  - Burke-Fraga V
FAU - Gonzalez-de la Parra, Mario
AU  - Gonzalez-de la Parra M
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 0 (Capsules)
RN  - 0 (Drugs, Generic)
RN  - 13T4O6VMAM (Piroxicam)
SB  - IM
MH  - Administration, Oral
MH  - Adult
MH  - Anti-Inflammatory Agents, Non-Steroidal/*administration & dosage/adverse 
      effects/blood/*pharmacokinetics
MH  - Biological Availability
MH  - Capsules
MH  - Chemistry, Pharmaceutical
MH  - Chromatography, High Pressure Liquid
MH  - Cross-Over Studies
MH  - Drugs, Generic/*administration & dosage/adverse effects/*pharmacokinetics
MH  - Female
MH  - Humans
MH  - Male
MH  - Mexico
MH  - Piroxicam/*administration & dosage/adverse effects/blood/*pharmacokinetics
MH  - Therapeutic Equivalency
MH  - Young Adult
EDAT- 2010/03/09 06:00
MHDA- 2010/05/29 06:00
CRDT- 2010/03/09 06:00
PHST- 2010/01/07 00:00 [accepted]
PHST- 2010/03/09 06:00 [entrez]
PHST- 2010/03/09 06:00 [pubmed]
PHST- 2010/05/29 06:00 [medline]
AID - S0149-2918(10)00053-6 [pii]
AID - 10.1016/j.clinthera.2010.02.002 [doi]
PST - ppublish
SO  - Clin Ther. 2010 Feb;32(2):357-64. doi: 10.1016/j.clinthera.2010.02.002.