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A single center, randomized, controlled trial in healthy volunteers using dermal open flow microperfusion to assess cutaneous BE of two doxepin hydrochloride creams
EU CTIS ID: 2026-526078-18-00
What this study is testing
Pilot study: To identify the target dose for the dOFM pivotal BE study. Pivotal study: Assess dermal bioequivalence (BE) between the test T and reference R topical formulations of doxepin hydrochloride based on dermal PK parameter obtained via dOFM.
- Human Pharmacology (Phase I)- Bioequivalence Study
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subject must be 18 to 65 years of age (both inclusive), at the time of signing the informed consent.
- “Healthy Subjects” according to definition in the FDA draft guidance on BE studies with PK endpoints, i.e. subjects who are non-smoking adults 18 years of age or older without existing medical conditions or required medications other than allowed as per Exclusion Criterion (EC) no. 6.
- BMI within the range 18-30 kg/m2 (both inclusive)
- Males or non-pregnant, non-breast-feeding females. WOCBP have to use adequate contraceptive methods for at least 4 weeks prior to scheduled Visit 2. There are no requirements for contraception for male participants.
- Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in this protocol
You likely can't join if
- Known or suspected hypersensitivity to the study interventions or related products, including but not limited to doxepin hydrochloride.
- Positive alcohol breath test.
- Positive urine drug screen.
- Clinically significant abnormal laboratory evaluation results, as deemed by the investigator.
- Positive serology results for hepatitis B antigen or hepatitis C. In case of the positive screening test, the relevant confirmatory test is decisive
- Positive human immunodeficiency virus (HIV) test. In case of the positive screening test, the relevant confirmatory test is decisive.
See the full eligibility criteria
Who can join
- Subject must be 18 to 65 years of age (both inclusive), at the time of signing the informed consent.
- “Healthy Subjects” according to definition in the FDA draft guidance on BE studies with PK endpoints, i.e. subjects who are non-smoking adults 18 years of age or older without existing medical conditions or required medications other than allowed as per Exclusion Criterion (EC) no. 6.
- BMI within the range 18-30 kg/m2 (both inclusive)
- Males or non-pregnant, non-breast-feeding females. WOCBP have to use adequate contraceptive methods for at least 4 weeks prior to scheduled Visit 2. There are no requirements for contraception for male participants.
- Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in this protocol
What rules you out
- Known or suspected hypersensitivity to the study interventions or related products, including but not limited to doxepin hydrochloride.
- Positive alcohol breath test.
- Positive urine drug screen.
- Clinically significant abnormal laboratory evaluation results, as deemed by the investigator.
- Positive serology results for hepatitis B antigen or hepatitis C. In case of the positive screening test, the relevant confirmatory test is decisive
- Positive human immunodeficiency virus (HIV) test. In case of the positive screening test, the relevant confirmatory test is decisive.
- Any abnormalities found during physical examination or vital signs, unless deemed not clinically significant by the investigator
- TEWL > 20 g/m²*h (measured on the thighs)
- Smoking (including vaping, e-cigarettes, and other nicotine delivery systems): Subjects must be non-smokers for at least 6 months at screening and have to refrain from smoking etc. until follow-up. Measure: Oral information on smoking status
- History of drug and/or alcohol abuse within one year before screening as judged by the investigator.
- Any reason, which in the opinion of the investigator, would prevent the subject from safely participating in the study.
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological or inherited blood disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study interventions; or interfering with the interpretation of data.
- Tattoos or broken and/or damaged skin and/or scarring at the application sites.
- Subjects prone to keloid or hypertrophic scar formation or any known wound healing disorder.
- History of severe allergies to drugs or foods, as well as plaster allergy, or a history of severe anaphylactic reaction.
- Not willing to avoid excessive sun exposure, steam baths, sauna, swimming, and other strenuous activities for 14 days after intervention visit (Visit 2) to ensure good tissue regeneration
- Pronounced hairiness on the planned application sites that may negatively affect BE testing.
- Not willing to refrain from shaving the planned application sites or using skin care products on the planned application sites for at least 5 days before intervention visit (Visit 2).
- Not willing to abstain of alcohol on the day of discharge from Visit 2 and omit driving the car on the day of discharge from intervention visit (Visit 2).
- Presence of needle phobia.
- Increased risk of thrombosis e.g., personal or first-degree relative(s) history of deep vein thrombosis.
- Presence of any clinically relevant acute or chronic disease, especially current psychiatric disorder, which in the investigator´s opinion might jeopardize subject’s safety, evaluation of results or compliance with the protocol.
- Recent and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc.), as judged by the investigator.
- Presence of known thrombophilia, active cancer, significant varicose veins with phlebitis, glaucoma, benign prostatic hypertrophy, urinary retention or recent major surgery or trauma.
- Not willing to abstain from any medications (prescription or nonprescription drugs (including vitamins, and dietary or herbal supplements)) other than hormonal contraceptive, hormone replacement therapy within 7 days (or 5 half-life periods, whichever is longer) before dosing of study interventions until completion of the intervention visit (Visit 2), unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study.
- Use of monoamine oxidase (MAO) inhibitors, including isocarboxazid, phenelzine and tranylcypromine 2 weeks before screening for the study.
- Current enrollment or past participation in another investigational study in which an investigational intervention (e.g., drug, vaccine, invasive device) was administered within 30 days before signing of consent in this clinical study.
- Clinically significant abnormal 12-lead ECG at screening, as deemed by the investigator.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.