Oral Bioequivalence Study of Lumateperonecapsule 42 Mg in Healthy Indian Subjects Underfasting Conditions

Objective: To compare the rate and extent of absorption and also to monitor the safety and tolerability of a single dose of Lumateperone Capsule 42 mg of Test drug with Reference Product CAPLYTA® (Lumateperone) 42 mg capsule. Design: Open label, balanced, randomized single-dose, two-treatment, two-sequence, two-period two-way Crossover design. Conclusion: The 90% confidence intervals of the differences of least squares means for the Ln- transformed pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞ of Lumateperone were within the bioequivalence acceptance limits of 80.00 - 125.00% and thus the test product (T) Lumateperone Capsule 42 mg and reference product (R) CAPLYTA® (Lumateperone) capsule 42 mg were found bioequivalent with respect to rate and extent of absorption. The 42 mg oral dose of Lumateperone was well tolerated and was found safe.