NCT03156439

Bioavailability, Safety, and Tolerability of BIS-001 ER

Evaluation of the Bioavailability, Safety, and Tolerability of BIS-001 ER Following Multiple Dose Administration in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Supernus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study investigates the safety, tolerability, and pharmacokinetics of BIS-001 ER in healthy volunteers. Subjects will be dosed twice daily, with a dose escalation occurring every 2-3 days until a maximum dose of 5mg per day is reached.

Conditions

• Epilepsy, Complex Partial

Interventions

Type	Name	Description
DRUG	BIS-001 ER	BIS-001 ER is an extended release formulation of the nutritional supplement Huperzine A.

Timeline

• Start date: 2017-05-22
• Primary completion: 2017-09-30
• Completion: 2017-09-30
• First posted: 2017-05-17
• Last updated: 2018-01-18

Locations

1 site across 1 country: Australia