DeepMed Research

JOANNEUM RESEARCH Forschungsgesellschaft mbH

🇦🇹Austria

Country: 🇦🇹Austria

Ownership: -

Employees: -

Market Cap: -

Website

Clinical Trials

Evaluate the Ability of dOFM for BE Testing of Topically Applied Diclofenac Sodium Products in Healthy Subjects

Not Applicable

Completed

Conditions: Healthy

Interventions: Drug: Voltaren - Diclofenac sodium gel 1% (GSK, USA)
Drug: Pennsaid 2 % Topical Solution (Horizon Therapeutics, USA)
Device: Dermal open flow microperfusion - Pilot
Drug: Diclofenac sodium gel 1% (Perrigo, USA)
Device: Dermal open flow microperfusion - Pivotal
Procedure: Blood sampling - Pilot
Procedure: Blood sampling - Pivotal

First Posted Date: 2020-10-19

Last Posted Date: 2022-08-26

Lead Sponsor: Joanneum Research Forschungsgesellschaft mbH

Target Recruit Count: 22

Registration Number: NCT04592016

Locations: 🇦🇹
CTU - Clinical Trials Unit, Medical University Graz, Graz, Austria

An Exploratory Study in Healthy Volunteers to Identify Factors Influencing Bioequivalence Studies on Moderately Lipophilic Drugs Using Dermal Open Flow Microperfusion (dOFM)

Not Applicable

Completed

Conditions: Healthy
Dermal Pharmacokinetic Measurements

Interventions: Drug: Lidocaine 2.5% and Prilocaine 2.5% cream, USP (Actavis Pharma incorporated, USA)
Drug: Lidocaine 2.5% and Prilocaine 2.5% cream (E. Fougera & Co. a division of Fougera Pharmaceuticals Inc., USA)
Drug: Oraqix Parodontal-Gel (Dentsply Detrey GmbH, Germany)
Device: Dermal open flow microperfusion
Procedure: Blood sampling

First Posted Date: 2019-08-08

Last Posted Date: 2020-10-12

Lead Sponsor: Joanneum Research Forschungsgesellschaft mbH

Target Recruit Count: 20

Registration Number: NCT04050826

Locations: 🇦🇹
CTU - Clinical Trials Unit, Medical University Graz, Graz, Austria

An Exploratory Study in Healthy Volunteers to Investigate the Cross-talk Between Local Drug Concentrations in the Skin and Systemic Concentrations During Topical Bioequivalence Studies Using Dermal Sampling Techniques

Not Applicable

Completed

Conditions: Healthy
Dermal Pharmacokinetic Measurement

Interventions: Drug: Lidocaine 2.5% and Prilocaine 2.5% cream", USP (2.5% lidocaine, 2.5% prilocaine, Actavis Pharma incorporated, USA)
Procedure: Intravenous infusion of lidocaine
Device: Dermal open flow microperfusion
Device: Dermal Microdialysis
Drug: Lidocorit 2%-Ampullen" (Gebro Pharma Gesellschaft mit beschränkter Haftung, Austria)
Procedure: Blood sampling in dermal sampling visit
Procedure: Blood sampling in clearance visit

First Posted Date: 2019-01-23

Last Posted Date: 2023-02-10

Lead Sponsor: Joanneum Research Forschungsgesellschaft mbH

Target Recruit Count: 26

Registration Number: NCT03813030

Locations: 🇦🇹
Clinical Research Center, Medical University Graz, Graz, Austria

An Exploratory Pilot Study in Healthy Volunteers to Assess the Parameters for the Design of Bioequivalence Studies on Moderately Lipophilic, Moderately to Highly Protein Bound Drugs Using Dermal Open Flow Microperfusion (dOFM)

Not Applicable

Completed

Conditions: Dermatology/Skin - Other
Dermal Pharmacokinetic Measurements

Interventions: Other: Dermal pharmacokinetic measurement
Drug: Lidocaine and prilocaine cream
Drug: Oraqix® gel
Device: dOFM-System
Procedure: Blood sampling

First Posted Date: 2018-08-03

Last Posted Date: 2018-08-03

Lead Sponsor: Joanneum Research Forschungsgesellschaft mbH

Target Recruit Count: 6

Registration Number: NCT03613207

Locations: 🇦🇹
HEALTH - Joanneum Research, Graz, Austria

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