Bioavailability Clinical Trial of Oral Minoxidil 1 mg
Status:
Enrolling by invitation
Trial end date:
2024-05-01
Target enrollment:
Participant gender:
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.