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ERG’s mission is to provide the highest quality clinical trial execution across all clinical research phases to help sponsors.
Clinical Pharmacology of Miami
Transdermal Patch Study Resulting in FDA Approval
ERG successfully conducted a Phase 1, open-label, 2-period crossover pharmacokinetics study comparing 2 transdermal delivery systems that contributed to the FDA approval.
Participant Criteria
- 18-55 years old
- BMI 18 kg/m2 to 32kg/m2, inclusive
- Nonsmokers
16%
Faster Timeline
40%
Screen Fail Rate Enrollment Goal Met
96%
Retention Rate Completion Goal Exceeded
We wish to thank your hard work and dedication to bringing this approval to fruition. 2021 was a challenge for everyone due to Covid, but your persistence and accountability during the hardest of times should be commended. Thank you very much for being a part of our success. We welcome the opportunity to work with you again in the future. — Sr. Director, Clinical Operations & Team
Trial Design
Screening: 28 days
In-Patient Treatment: 61 days
Follow-up (Phone): 5-7 days
Total: 96 days
Sponsor Enrollment Expectations
An adequate number of subjects will enter the Screening Period to enroll approximately 54 subjects, to complete with approximately 42 subjects.
Patch Placement: naïve location on back avoiding bra and waistline
Period 1
7-day treatment
28-day washout
Period 2
7-day treatment
19-day washout
- 58 PK Samples total per subject
- Adhesion assessment: utilize 5-point scale every
- 12 hours supplemented with photo evidence
- Skin tolerability: Dermal response combined with Other Effects scale at 4 time points
- Residual assessment
