Bioavailability Clinical Trial of Oral Minoxidil 1 mg

Healthy Clinical Trial

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

Status Enrolling by invitation

Clinical Trial Summary

The goal of this clinical trial is to learn about the pharmacokinetic profile (behaviour of the drug in the body) of a new oral formulation of minoxidil administered in healthy volunteers.

The main question that is to answer is to evaluate the bioavailability of the oral test formulation of minoxidil. The secondary onjectives is to compare it with the formulation already on the market (i.e . Regaxidil® 20 mg/mL cutaneous solution).

It is planned that 14 healthy female volunteers of legal age (without any known pathology) participate in the study. The expected duration of the study is approximately 23-56 days.

Each volunteer that decide to participate in this study will be sequentially administered one of the formulations planned for the study: either the test formulation (oral minoxidil tablets of 1 mg, developed by Industrial Farmacéutica Cantabria, S.A.), or the reference formulation (minoxidil skin solution, 20 mg/mL, marketed by Industrial Farmacéutica Cantabria, S.A.). After five days of administration of one of the study formulations, at least 7 days will elapse before starting an additional five days of administration of the other study formulation that had not been administered in the first sequence. Assignment to this sequence of administration of the study formulations (oral formulation or topical solution) shall be completely randomised.

In each of these sequential periods of five days of administration of the study formulations, the concentration of minoxidil will be quantified in blood samples, which will be taken from each of the volunteers at certain times after the administration of the medication. These blood analyses will enable to determine the parameters that define the pharmacokinetic profile of the new oral formulation under study.

Clinical Trial Description

This is a phase I, oral multiple-dose, open-label, crossover and randomized clinical trial, 2 sequences, 2 periods, in which subjects will be hospitalized from 10 h before to 12 hours after the first and fifth doses under fasting conditions in both periods.

The study will be blinded only for the plasma concentrations determination of minoxidil.

It is planned to include 14 healthy women volunteers, aged from 18 to 55 years old. The overall duration of the study is estimated at 24-56 days, from recruitment of the volunteers to the last examination.

The test drug is minoxidil 1 mg tablets, manufactured by Industrial Farmacéutica Cantabria, S.A. It will be administered a total of five 1 mg doses (once a day) per oral, under fasting conditions. The reference drug is minoxidil 20 mg/ml (2%) topical solution, marketed in Spain by Industrial Farmacéutica Cantabria, S.A., under the name the trade name of Regaxidil®. It will be applied five 1 mL doses (once a day) topical route, under fasting conditions.

Each one of the subjects will receive a daily dose during five days of minoxidil test or reference in each one of the two periods according to the corresponding randomization sequence, after at least 7 days washout period between each one of admission days.

The main objective is to evaluate the relative bioavailability of the oral test formulation of minoxidil 1 mg after single dose and multiple dose (at steady state). The bioavailability of oral formulation will be evaluated from the AUC0-t and Cmax for single dose on the first administration day and AUC(0-τ)SS, Cmax,ss and Cτ,ss on the steady state of minoxidil. Tmax and Tmax,ss and fluctuation of minoxidil will be also calculated. All the pharmacokinetic parameters will be calculated from the plasma concentrations of minoxidil of the formulation. ;

Related Conditions & MeSH terms

• Healthy

• NCT number: NCT06015516
• Study type: Interventional
• Source: Industrial Farmacéutica Cantabria, S.A.
• Status: Enrolling by invitation
• Phase: Phase 1
• Start date: February 9, 2024
• Completion date: May 2024