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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

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-526078-18-00
Enrollment
24
Registered
2026-07-17
Start date
Unknown
Completion date
Unknown
Last updated
2026-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

No medical condition is being investigated in this clinical trial.

Brief summary

Pilot study: Dermal PK profiles (dOFM-measured concentration-time curves) for the target dose 1 and target dose 2., Pilot study: Dermal PK parameters (AUC(0 to 24)h, Cmax, tmax) for the target dose 1 and target dose 2., Pivotal BE study: Dermal PK profiles across subjects., Pivotal BE study: Dermal PK parameters AUC and Cmax of T and R and their descriptive statistics., Pivotal BE study: BE statistics: geometric mean ratios, variability estimates and confidence limits.

Interventions

DRUGDOXEPIN HYDROCHLORIDE

Sponsors

Medical University Of Graz
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Pilot study: Dermal PK profiles (dOFM-measured concentration-time curves) for the target dose 1 and target dose 2., Pilot study: Dermal PK parameters (AUC(0 to 24)h, Cmax, tmax) for the target dose 1 and target dose 2., Pivotal BE study: Dermal PK profiles across subjects., Pivotal BE study: Dermal PK parameters AUC and Cmax of T and R and their descriptive statistics., Pivotal BE study: BE statistics: geometric mean ratios, variability estimates and confidence limits.—

Outcome results

None listed

Source: EU CTIS · Data processed: Jul 18, 2026