NCT06679556

Phase 1 Pharmacokinetic Study of Minoxidil SL Tablets

A Phase 1 Randomized, Double Blind, Crossover Pharmacokinetic Study of Minoxidil Sublingual Tablets in Adult Male and Female Healthy Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Samson Clinical Operations Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1 randomized, double blind, crossover study examining the pharmacokinetic profile of two different doses of minoxidil sublingual tablets in healthy adult volunteers. The main objective is to determine the pharmacokinetics of minoxidil following sublingual administration of a single dose in adult male and female healthy volunteers. The secondary objective is to evaluate the safety of minoxidil following sublingual administration of a single dose in adult male and female healthy volunteers. A total of 12 participants (6 male and 6 female) will be recruited for study participation. The duration of study participation is up to 43 days including screening and safety follow up. A single dose of study medication (strength A or strength B) will be administered on Day 1 to all study participants and PK samples will be taken periodically over a 12-hr period. After at least 7-day washout period the other dose of study medication (strength B or strength A, respectively) will be administered to all participants and PK samples will be taken periodically over a 12-hr period.

Conditions

• Pharmacokinetic

Interventions

Type	Name	Description
DRUG	Strength A Sublingual Minoxidil	One single dose of Strength A sublingual minoxidil
DRUG	Strength B Sublingual Minoxidil	One single dose of Strength B sublingual minoxidil

Timeline

• Start date: 2024-11-06
• Primary completion: 2024-12-23
• Completion: 2024-12-23
• First posted: 2024-11-07
• Last updated: 2025-02-17

Locations

1 site across 1 country: Australia