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Phase 1 Pharmacokinetic Study of Minoxidil SL Tablets

NCT06679556 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-02-17

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Samson Clinical Operations Pty Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-06
Primary Completion
2024-12-23
Completion
2024-12-23

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06679556 on ClinicalTrials.gov