Randomised, Crossover Bioavailability Clinical Trial of Oral Minoxidil 1 MG, After Single and Multiple Dose Administration to Healthy Volunteers Under Fasting Conditions.
Minoxidil Tablets
+ Minoxidil topical solution 20 mg/ml
Other Study
Summary
Study start date: February 9, 2024
Actual date on which the first participant was enrolled.This clinical trial is focused on understanding how the body absorbs and processes a new oral form of minoxidil, a medication usually used to treat hair loss. The study specifically targets healthy women between the ages of 18 and 55. By comparing the new oral tablet form of minoxidil to the existing topical solution, the research aims to see how much of the drug actually gets into the bloodstream when taken as a pill. This information could be crucial for developing new treatment methods that may be more effective or convenient for patients. During the study, participants receive either the oral minoxidil tablet or the topical solution in a specific order. Each participant takes the medication once a day for five days, with a break of at least seven days between different treatments to ensure accurate results. The researchers measure how much of the drug is present in the blood at different times to understand how the body absorbs it. The study is designed as a crossover trial, meaning each participant tries both forms of the medication, allowing for a direct comparison of the two methods. The main focus is on determining how effectively the body takes in the oral form compared to the topical solution.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.14 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 18 to 55 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Hospital Universitario de la Princesa
Madrid, SpainOpen Hospital Universitario de la Princesa in Google Maps