NCT05102552

Evaluating the Safety and Relative Bioavailability of Three SPN-817 Treatments (A, B and C) in Healthy Adult Subjects

A Single-Center, Randomized, Open-label, Multiple-Dose, Single-Sequence Crossover Study, Evaluating the Safety and Relative Bioavailability of Three SPN-817 Treatments (A, B and C) in Healthy Adult Subjects

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Supernus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Randomized, Open-Label, Multiple Dose study to evaluate the relative bioavailability of Treatment A, Treatment B, and Treatment C

Detailed description

A Single-Center, Randomized, Open-label, Multiple-Dose, Single-Sequence Crossover Study, Evaluating the Safety and Relative Bioavailability of Three SPN-817 Treatments (A, B and C) in Healthy Adult Subjects

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	SPN-817, Treatment B	SPN-817 Treatment B, is an Extended Release formulation of Huperzine A, an acetylcholinesterase inhibitor
DRUG	SPN-817, Treatment C	SPN-817 Treatment C, is an Extended Release formulation of Huperzine A, an acetylcholinesterase inhibitor
DRUG	BIS-001, Treatment A	BIS-001 is an Extended Release formulation of Huperzine A, an acetylcholinesterase inhibitor

Timeline

• Start date: 2021-10-19
• Primary completion: 2022-03-25
• Completion: 2022-08-15
• First posted: 2021-11-01
• Last updated: 2022-08-30

Locations

1 site across 1 country: Australia