Expert opinion on drug delivery · 2025
Comparison of the pharmacokinetics of MR-107A-02, a novel fast-absorbing formulation of meloxicam, versus standard meloxicam reference: a phase I study.
СтатьяРандомизированное исследованиеКлиническое исследование I фазыСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Hummel Matthew A, Shaw Andrew, Liu Mark Shiyao, Jaiswal Amarnath, Smith Jeffrey P, Bertoch Todd
Аннотация
BACKGROUND: MR-107A-02 is a novel faster dissolving oral formulation of meloxicam to provide rapid absorption and faster onset of action in acute pain settings. This study compared the single-dose pharmacokinetics of MR-107A-02 tablets to reference meloxicam (Mobic®) tablets under fasting conditions.
RESEARCH DESIGN AND METHODS: A single-dose, randomized, two-period crossover study was conducted at a single center in India. Healthy adult volunteers, aged 18-45 years, were randomized to receive a single, oral dose of 15 mg (1 × 15 mg) of MR-107A-02 or reference. Plasma samples were analyzed for meloxicam using LC-MS/MS. Pharmacokinetic parameters were derived using non-compartmental analysis, and 90% geometric confidence intervals for test/reference ratios were calculated. Safety was assessed through adverse event (AE) monitoring.
RESULTS: Eighteen adult male volunteers were randomized and 16 completed the study. MR-107A-02 showed faster absorption, with a geometric mean Cmax value of 2734.342 (ng/mL) compared to reference 1592.102 (ng/mL) and a significantly shorter median Tmax (hour) (0.75 vs 4.00). There were no AEs, or serious AEs reported.
CONCLUSIONS: MR-107A-02 demonstrated more rapid absorption than reference, as evidenced by a higher Cmax, and shorter Tmax values. These findings highlight the potential utility of oral MR-107A-02's fast-release design in an acute pain setting.
RESEARCH DESIGN AND METHODS: A single-dose, randomized, two-period crossover study was conducted at a single center in India. Healthy adult volunteers, aged 18-45 years, were randomized to receive a single, oral dose of 15 mg (1 × 15 mg) of MR-107A-02 or reference. Plasma samples were analyzed for meloxicam using LC-MS/MS. Pharmacokinetic parameters were derived using non-compartmental analysis, and 90% geometric confidence intervals for test/reference ratios were calculated. Safety was assessed through adverse event (AE) monitoring.
RESULTS: Eighteen adult male volunteers were randomized and 16 completed the study. MR-107A-02 showed faster absorption, with a geometric mean Cmax value of 2734.342 (ng/mL) compared to reference 1592.102 (ng/mL) and a significantly shorter median Tmax (hour) (0.75 vs 4.00). There were no AEs, or serious AEs reported.
CONCLUSIONS: MR-107A-02 demonstrated more rapid absorption than reference, as evidenced by a higher Cmax, and shorter Tmax values. These findings highlight the potential utility of oral MR-107A-02's fast-release design in an acute pain setting.