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

Author(s)	Mr. Prashant Kumthekar, Mr. Mahesh Bhale, Mr. Sunil Mirajkar, Mr. Mihir Upadhyay
Country	India
Abstract	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.
Keywords	LUMATEPERONE, 42 MG,
Field	Medical / Pharmacy
Published In	Volume 8, Issue 1, January-February 2026
Published On	2026-01-04
DOI	https://doi.org/10.36948/ijfmr.2026.v08i01.65539
Short DOI	https://doi.org/hbhsf3

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