Status:
COMPLETED
Bioavailability Clinical Trial of Oral Minoxidil 1 mg
Lead Sponsor:
Industrial Farmacéutica Cantabria, S.A.
Conditions:
Healthy
Eligibility:
FEMALE
18-55 years
Phase:
PHASE1
Brief 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 q...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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.
- No clinically significant abnormalities in haematology, coagulation, biochemistry, serology (Ag HBs, HC antibodies, HIV antibodies) and urinalysis.
- No clinically significant abnormalities in vital signs and electrocardiogram.
- Women of child-bearing potential age women participating in the study will compromise to use a high effective contraceptive method or will be abstinent during their participation in the study.
Exclusion
- 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.
- Positive drug screening for cannabis, opiates, cocaine and amphetamines.
- Smoker.
- Daily consumers of alcohol and/or acute alcohol poisoning over the last week.
- Having donated blood in the last month before start of the study.
- Pregnant or breastfeeding women.
- Participation in another study with administration of investigational drugs in the previous 3 months (if the study was conducted with drug substances marketed in Spain, a period of at least 1 month or 5 half lives, what is longer, will be considered).
- Inability to follow the instructions or collaborate during the study.
- History of difficulty in swallowing
- Alterations on the scalp such as erythema, dryness or any other condition that at investigator criteria could affect the absortion of the topical solution.
Key Trial Info
Start Date :
February 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 8 2024
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT06015516
Start Date
February 9 2024
End Date
March 8 2024
Last Update
August 21 2024
Active Locations (1)
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1
Hospital Universitario de la Princesa
Madrid, Spain, 28006