Pharmacokinetics and Bioequivalence of Mirogabalin Orally Disintegrating Tablets and Conventional Tablets in Healthy Japanese Participants

• Published in: Clinical pharmacology in drug development Vol. 12; no. 10; pp. 985 - 990
• Main Authors: Toyama, Kaoru, Eto, Takashi, Suzuki, Kanae, Shinohara, Sayaka, Yoshiba, Satoshi, Yoshihara, Kazutaka, Ishizuka, Hitoshi
• Format: Journal Article
• Language: English
• Published: United States Wiley Subscription Services, Inc 01.10.2023
• Subjects: Bioequivalence; Plasma; orally disintegrating tablet; mirogabalin; neuropathic pain; bioequivalence

This single‐center, randomized, open‐label, single‐dose, 2‐group, 2‐stage crossover trial evaluated the bioequivalence of 15 mg of mirogabalin as orally disintegrating tablets (ODTs) with conventional mirogabalin tablets in healthy Japanese men. The trial involved two studies: in Study 1, the ODT fo...