NCT07266792

Bioequivalence Study to Compare Brexpiprazole 4 mg Film Coated Tablets Versus RXULTI 4 mg Film Coated Tablet (Brexpiprazole)

An Open Label, Randomized, Two-period, Twotreatment, Two-sequence, Truncated, Crossover, Balanced, Single Dose Oral Bioequivalence Study.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Humanis Saglık Anonim Sirketi · Industry
• Sex: All
• Age: 45 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Single dose oral bioequivalence study of Brexpiprazole 4 mg Film Coated Tablets and RXULTI® (Brexpiprazole) 4 mg film-coated tablets in healthy adult human subjects under fasting conditions.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Brexpiprazole Film Coated Tablets	1 tablet of Brexpiprazole 4 mg Film Coated Tablets
DRUG	RXULTI film coated tablet	1 tablet of RXULTI 4 mg film coated tablet (Brexpiprazole)

Timeline

• Start date: 2025-06-22
• Primary completion: 2025-08-04
• Completion: 2025-10-07
• First posted: 2025-12-05
• Last updated: 2025-12-05

Locations

1 site across 1 country: India