Bioequivalence study of a novel orodispersible tablet of meloxicam in a porous matrix after single-dose administration in healthy volunteers

Radicioni, Milko; Connolly, Sandra M.; Stroppolo, Federico; Granata, Gabriele; Loprete, Luca; Leuratti, Chiara

doi:10.5414/cp201781

Cited by 5 publications

(3 citation statements)

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“…compared the bioavailability of meloxicam after oral an orodispersible tablet (15 mg/dose) with a reference tablet in healthy human under fasting condition. They found that the test and reference formulations met the regulatory criteria for bioequivalence in terms of AUC and C max regardless of the rapid disintegration of orodispersible tablet . Similarly, Helmy and Bedaiwy investigated the impact of formulation factor on the pharmacokinetic parameters and the bioequivalence of a commercial suspension and tablet formulations of meloxicam (15 mg/dose) in male volunteers under fasting conditions .…”

Section: Discussionmentioning

confidence: 99%

“…They found that the test and reference formulations met the regulatory criteria for bioequivalence in terms of AUC and C max regardless of the rapid disintegration of orodispersible tablet. [16] Similarly, Helmy and Bedaiwy investigated the impact of formulation factor on the pharmacokinetic parameters and the bioequivalence of a commercial suspension and tablet formulations of meloxicam (15 mg/dose) in male volunteers under fasting conditions. [17] They concluded that a single oral administration Table 3 Pharmacokinetic parameters for meloxicam formulation including R (Mobic â ), products A and B (data were shown as mean AE SD, n = 9) of the suspension formulation met comparable clinical outcomes as compared with the reference tablet.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Evaluating bioequivalence of meloxicam tablets: is in-vitro dissolution test overdiscriminating?

Jin

Zhao

Shen

et al. 2018

Journal of Pharmacy and Pharmacology

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Evaluating bioequivalence of meloxicam tablets: is in-vitro dissolution test overdiscriminating?

Jin

Zhao

Shen

et al. 2018

Journal of Pharmacy and Pharmacology

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“…In recent years, increasing attention has been paid to the PK of meloxicam. 16,17 However, few studies have been performed in Chinese HVs. 18,19 This study, with fasting and fed arms, was performed to investigate the BE of meloxicam from 2 manufacturers.…”

Section: Discussionmentioning

confidence: 99%

Pharmacokinetics of Meloxicam Tablets in Healthy Chinese Adults in the Fasting and Fed States: A Single‐Site, Single‐Dose, Randomized, Open, 2‐Period, 2‐Sequence, Crossover Bioequivalence Study

Yü

Wang

et al. 2021

Clinical Pharm in Drug Dev

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Meloxicam is an enolate nonsteroidal anti-inflammatory agent. This trial investigated the pharmacokinetics, safety, and bioequivalence of single oral doses of Aomei meloxicam (15 mg) and Mobic meloxicam (15 mg) in healthy volunteers under fasting and fed conditions. A single-site, single-dose, randomized, open, 2-period, 2-sequence, crossover bioequivalence study was performed: 24 healthy volunteers were enrolled in each of the fasting and fed arms. Each HV was randomly assigned to receive the Aomei drug (test) in one period and the Mobic drug (reference) in the other period. The concentration of meloxicam in plasma was detected using liquid chromatography-tandem mass spectrometry. The primary pharmacokinetic parameters were calculated using a noncompartmental model. In the fasting arm, the 90% confidence interval of the geometric mean ratios of maximum plasma concentration, area under the concentration-time curve from time 0 to the last measurable plasma concentration, and area under the concentration-time curve from time 0 to infinity between the test and reference products were 99.5% to 111.7%, 101.2% to 106.8%, and 101.8% to 108.3%, respectively. In the fed arm, the 3 parameters were 94.1% to 102.4%, 97.6% to 103.0%, and 97.5% to 103.7%, respectively. These parameters were in the range of 80% to 125%, and the 2 products were considered bioequivalent in both the fasting and fed states and were well tolerated. The severity of all adverse events was mild. Aomei meloxicam tablets and Mobic meloxicam tablets were bioequivalent in healthy Chinese volunteers.

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Physiologically based pharmacokinetic (PBPK) modeling of meloxicam in different CYP2C9 genotypes

et al. 2021

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Bioequivalence study of a novel orodispersible tablet of meloxicam in a porous matrix after single-dose administration in healthy volunteers

Abstract: Test and reference formulations met the regulatory criteria for bioequivalence in the fasting healthy volunteers enrolled.

Cited by 5 publications

References 0 publications

Evaluating bioequivalence of meloxicam tablets: is in-vitro dissolution test overdiscriminating?

Evaluating bioequivalence of meloxicam tablets: is in-vitro dissolution test overdiscriminating?

Pharmacokinetics of Meloxicam Tablets in Healthy Chinese Adults in the Fasting and Fed States: A Single‐Site, Single‐Dose, Randomized, Open, 2‐Period, 2‐Sequence, Crossover Bioequivalence Study

Physiologically based pharmacokinetic (PBPK) modeling of meloxicam in different CYP2C9 genotypes

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