Completed

Randomised, Crossover Bioavailability Clinical Trial of Oral Minoxidil 1 MG, After Single and Multiple Dose Administration to Healthy Volunteers Under Fasting Conditions.

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What is being tested

Minoxidil Tablets

+ Minoxidil topical solution 20 mg/ml

Drug
Who is being recruted

From 18 to 55 Years
+20 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Phase 1
Interventional
Study Start: February 2024
See protocol details

Summary

Principal SponsorIndustrial Farmacéutica Cantabria, S.A.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleRandomised, Crossover Bioavailability Clinical Trial of Oral Minoxidil 1 MG, After Single and Multiple Dose Administration to Healthy Volunteers Under Fasting Conditions.
NCT06015516
Principal SponsorIndustrial Farmacéutica Cantabria, S.A.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

14 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

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

7 inclusion criteria required to participate
Women, who after receiving information about the study design, the objectives, the possible risks that could be derived from it and the fact that they can refuse to collaborate at any time, give their written informed consent to participate in the study.

Aged from 18 to 55 years old.

No clinically significant organic or psychic conditions.

No clinically significant abnormalities in medical records and physical examination.

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13 exclusion criteria prevent from participating
Subjects affected by an organic or psychic condition. Before a volunteer is included, all the safety parameters defined in points 7.3 will be considered. Those who present clinically significant analytical alterations and in whom biochemical kidney and/or liver damage markers are outside the normal range applied by the laboratory will be excluded [GOT, GPT and/or GGT >2.5*ULN and total bilirrubin >1.5*ULN (total bilirrubin >1.5*ULN is acceptable if the direct bilirrubin is <35%)].

Subjects who have received prescribed pharmacological treatment in the last 15 days or abstinent of medication in the 48 hours prior to receiving the study medication, but women are allowed taking contraceptives. Contraceptive methods must be used at least 4 weeks prior to entry visit and not to be changed for the duration of the study.

Subjects with body mass index (weight (kg)/height2 (m2)) outside the 18.5-30.0 range.

History of sensitivity to any drug.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will be administered one tablet of oral minoxidil 1mg once a day, orally, after fasting for at least 10 hours, with 240 mL or 8 Oz. of water, and fasting for a further 5 hours.

Group II

Active Comparator
Participants will be administered topically on the scalp after fasting for at least 10 hours pre-dose and 5 hours post-dose. After the administration subject should not wash her head for at least 5 hours. Each one mL dose of 2% topical minoxidil will be carefully measured to provide 20 mg of minoxidil using the syringe provided with each bottle.

Study 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

Suspended

Hospital Universitario de la Princesa

Madrid, SpainOpen Hospital Universitario de la Princesa in Google Maps
CompletedOne Study Center