Bioequivalence Study of Two Oral Methocarbamol Formulations in Healthy Subjects Under Fasting Conditions: A Randomized, Open-Label, Crossover Clinical Trial
<b>Objective:</b> This study aimed to assess the bioequivalence of two oral methocarbamol formulations, as follows: the test (T) methocarbamol 1500 mg tablets and the reference (R) Robaxin<sup>®</sup> 500 mg tablets (3 tablets, total dose: 1500 mg) under fasting conditions, a...
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| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2025-03-01
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| Series: | Pharmaceuticals |
| Subjects: | |
| Online Access: | https://www.mdpi.com/1424-8247/18/3/354 |
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| Summary: | <b>Objective:</b> This study aimed to assess the bioequivalence of two oral methocarbamol formulations, as follows: the test (T) methocarbamol 1500 mg tablets and the reference (R) Robaxin<sup>®</sup> 500 mg tablets (3 tablets, total dose: 1500 mg) under fasting conditions, and compare their pharmacokinetic performance. <b>Methods:</b> This was a single-center, phase I, randomized, open-label (blinded for analytical determination), two-sequence, two-period, crossover, bioequivalence study. A total of 32 healthy volunteers were randomly assigned to receive the T-R or R-T administration sequence. Each volunteer received a single dose of each methocarbamol formulation (T or R) separated by a washout period of 7 days. To evaluate the pharmacokinetic profile, blood samples were collected at nineteen time points after dosing. <b>Results:</b> The arithmetic mean C<sub>max</sub> was 31.72 µg/mL for R and 32.39 µg/mL for T, and the arithmetic mean AUC<sub>0−t</sub> was 90.25 h × µg/mL and 89.72 h × µg/mL, respectively. All adverse events reported were mild for both formulations. The 90% confidence intervals for the corresponding logarithmically transformed geometric mean ratios of C<sub>max</sub> and AUC<sub>0−t</sub> fell within the acceptance interval of 80.00–125.00%, as their values were 91.67–112.47% for ln(C<sub>max</sub>) and 92.34–103.47% for ln(AUC<sub>0−t</sub>). <b>Conclusion:</b> Therefore, one tablet of methocarbamol 1500 mg was found to be bioequivalent to the Robaxin<sup>®</sup> 500 mg tablets (3 tablets), with comparable tolerability and safety profiles. |
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| ISSN: | 1424-8247 |