Study to Evaluate the Relative Bioavailability of a New Formulation of NPT 2042 Soft-Gelatin Capsules Compared to the Original Formulation of NPT 2042
NCT07222878 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2026-04-03
Summary
A Single-center, Open-label, Single-dose, Three-period, Fixed Sequence Study to Evaluate the Relative Bioavailability of a New Formulation of NPT 2042 Soft-Gelatin Capsules
Conditions
- Epilepsy
- Alzheimer Disease
- Epilepsy Intractable
Interventions
- DRUG
-
NPT 2042 (Reference formula/Formulation 1)
In Period 1 Day 1, participants will receive Formulation 1 in a fasted state (Treatment A).
- DRUG
-
NPT 2042 (Test formula/Formulation 2)
Following a 3-day wash out, in Period 2 Day 1, participants will receive Formulation 2 in a fasted state (Treatment B).
- DRUG
-
NPT 2042 (Test formula/Formulation 2)
Following a 4-day wash out, in Period 3 Day 1, participants will receive Formulation 2 in a fasted state with co-administered agent (Treatment C).
Sponsors & Collaborators
-
NeuroPro Therapeutics, Inc.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 19 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-09-29
- Primary Completion
- 2025-11-04
- Completion
- 2025-11-04
- FDA Drug
- Yes
Countries
- United States
Study Locations
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