Bioequivalence and Comparative Pharmacokinetics of Two Generic Mirogabalin Besylate Tablets (5 mg and 10 mg) and Tarlige® in Healthy Chinese Volunteers: A Pooled Analysis of Two Randomized, Open-Label, Two-Period Crossover Studies

Key Points

• Bioequivalence was established, indicating that the two generic tablets are similar to Tarlige® in effect.
• The study compared 5 mg and 10 mg doses of generic mirogabalin tablets against Tarlige® in healthy volunteers.
• Randomized, open-label, two-period crossover studies provided robust comparisons of pharmacokinetics.
• Implications for clinical use include the potential for cost savings with the generic formulations.