Ignite Creation Date:
2024-05-06 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03613207
Status:
COMPLETED
Last Update Posted:
2018-08-03
First Post:
2018-07-03
Brief Title:
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
Sponsor:
Joanneum Research Forschungsgesellschaft mbH
Organization:
Joanneum Research Forschungsgesellschaft mbH
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overall aim of this clinical pilot study is to develop an optimal design eg dose study duration for the main clinical study In the main study factors that influence dOFM data variability will be measured to develop a general BE testing method using dOFM for dermatological drug products
Detailed Description:
In this herein described pilot study 6 subjects will receive three different topical doses of Lidocaine 25 and Prilocaine 25 cream 25 lidocaine 25 prilocaine ACTAVIS LABORATORIES UT INC US to select an optimal dose for the main study Oraqix gel 25 lidocaine 25 prilocaine Dentsply Pharmaceutical Inc US will be applied to assess whether it can be used as negative control in the main study Blood samples will also be drawn at prior to dosing to establish a baseline and at defined time points post-dose to assess systemic drug levels Furthermore lateral diffusion from a dosed site to an adjacent non-dosed test site will be evaluated in this pilot study Different non-invasive devices will be tested to identify influencing factors for skin penetration in order to complete the available information on skin characteristics for the main study
This pilot will be a single center open label exploratory research study to assess the dermal PK of marketed topical formulations of lidocaineprilocaine in six healthy volunteers using dOFM The study will be performed at the Clinical Research Center of the Medical University of GrazAustriaThe study comprises three visits a screening visit Visit 1 a study visit of approximately 28 h Visit 2 for application of dermatological drug products and an End-of-Study visit Visit 3 In Visit 2 each subject will have nine test sites four on the left thigh four on the right thigh resulting in 8 test sites on both thighs and one on the arm Each of the nine test site will have 2 dOFM probes resulting in 18 dOFM probes per subject On six of the eight test sites on the thighs three different doses of Lidocaine 25 and Prilocaine 25 cream cream will be applied 5 mgcm² 10 mgcm² or 15 mgcm² to assess the dose for the main study On another test site on the thighs Oraqix gel will be applied to check if Oraqix can be used as negative control in the main study On the remaining test site on the thighs as well as on the test site on the arm no products will be applied to test for potential cross-talk between test sites by lateral diffusion and systemic redistribution resulting in seven treated and two non-treated sites per subject Additionally 8 blood samples will be drawn to rule out systemic appearance of lidocaine andor prilocaine Further devices to identify possible factors influencing skin penetration will be measured on each thigh eg TEWL
This pilot will be a single center open label exploratory research study to assess the dermal PK of marketed topical formulations of lidocaineprilocaine in six healthy volunteers using dOFM The study will be performed at the Clinical Research Center of the Medical University of GrazAustriaThe study comprises three visits a screening visit Visit 1 a study visit of approximately 28 h Visit 2 for application of dermatological drug products and an End-of-Study visit Visit 3 In Visit 2 each subject will have nine test sites four on the left thigh four on the right thigh resulting in 8 test sites on both thighs and one on the arm Each of the nine test site will have 2 dOFM probes resulting in 18 dOFM probes per subject On six of the eight test sites on the thighs three different doses of Lidocaine 25 and Prilocaine 25 cream cream will be applied 5 mgcm² 10 mgcm² or 15 mgcm² to assess the dose for the main study On another test site on the thighs Oraqix gel will be applied to check if Oraqix can be used as negative control in the main study On the remaining test site on the thighs as well as on the test site on the arm no products will be applied to test for potential cross-talk between test sites by lateral diffusion and systemic redistribution resulting in seven treated and two non-treated sites per subject Additionally 8 blood samples will be drawn to rule out systemic appearance of lidocaine andor prilocaine Further devices to identify possible factors influencing skin penetration will be measured on each thigh eg TEWL
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DRKS00012706 | REGISTRY | German Clinical Trials Register | None |