Bioequivalence Study to Compare Cariprazine 1.5 mg Hard Capsules (1.5 mg Cariprazine Hydrochloride) Versus Reagila® 1,5 mg Hartkapseln (Hard Capsules) (Cariprazine)
NCT07691190 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2026-07-08
Summary
Single dose oral bioequivalence study of Cariprazine 1.5 mg Hard Capsules (1.5 mg Cariprazine hydrochloride) and Reagila® 1,5 mg Hartkapseln (Hard Capsules) (Cariprazine) in healthy adult human participants under fasting conditions.
Conditions
- SCHIZOPHRENIA 1 (Disorder)
Interventions
- DRUG
-
Cariprazine Hard Capsules
1 capsule of 1.5 mg Cariprazine hydrochloride
- DRUG
-
Reagila® Hartkapseln (Hard Capsules) (Cariprazine)
1 capsule of 1.5 mg Cariprazine
Sponsors & Collaborators
-
Humanis Saglık Anonim Sirketi
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-03-05
- Primary Completion
- 2026-06-02
- Completion
- 2026-06-26
Countries
- India
Study Locations
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