Bioavailability Clinical Trial of Oral Minoxidil 1 mg

PHASE1CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

February 9, 2024

Primary Completion Date

March 8, 2024

Study Completion Date

March 8, 2024

Conditions
Healthy
Interventions
DRUG

Minoxidil Tablets

"Since oral minoxidil is a new formulation and, according to the recommendations of the Regulatory Authorities, it is considered appropriate to carry out a multiple dose study to evaluate and to compare the bioavailability between both formulations (oral versus topical solution), measuring the plasma concentrations of minoxidil.~Achievement of steady-state is assessed by comparing at least three pre-dose concentrations for each formulation, as half-life of minoxidil is around 4 hours, we will administered 5 doses in each period."

DRUG

Minoxidil topical solution 20 mg/ml

"Since oral minoxidil is a new formulation and, according to the recommendations of the Regulatory Authorities, it is considered appropriate to carry out a multiple dose study to evaluate and to compare the bioavailability between both formulations (oral versus topical solution), measuring the plasma concentrations of minoxidil.~Achievement of steady-state is assessed by comparing at least three pre-dose concentrations for each formulation, as half-life of minoxidil is around 4 hours, we will administered 5 doses in each period."

Trial Locations (1)

28006

Hospital Universitario de la Princesa, Madrid

All Listed Sponsors
lead

Industrial Farmacéutica Cantabria, S.A.

INDUSTRY

NCT06015516 - Bioavailability Clinical Trial of Oral Minoxidil 1 mg | Biotech Hunter | Biotech Hunter