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The purpose of this study is to characterize the comparative single-dose pharmacokinetics (bioequivalence) of lidocaine patch 1.8% (investigational product) versus Lidoderm® (lidocaine patch 5%,reference product).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine Patch (Sequence AB) | Experimental | Subjects received all study treatments: ZTlido and Lidoderm. On Day 1 (Period 1), three ZTlido lidocaine topical systems were applied to the skin on the back for 12 hours. On Day 8 (Period 2), three Lidoderm lidocaine patches were applied to the skin on the back for 12 hours. |
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| Lidocaine Patch (Sequence BA) | Experimental | Subjects received all study treatments: ZTlido and Lidoderm. On Day 1 (Period 1), three Lidoderm lidocaine patches were applied to the skin on the back for 12 hours. On Day 8 (Period 2), three ZTlido lidocaine topical systems were applied to the skin on the back for 12 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine topical system 1.8% | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration (Cmax) of lidocaine | Peak plasma concentration of lidocaine after application of 3 patches for 12 hours | 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose |
| Area under the Plasma-Concentration Time Curve (AUC) from Time 0 to Time 48 hours | Area under the plasma concentration versus time curve from 0 to 48 hours of lidocaine in plasma | 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose |
| Area under the Plasma-Concentration Time Curve (AUC) from Time 0 to Time Infinity | Area under the plasma concentration versus time curve from 0 to infinite time of lidocaine in plamsa | 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose |
| Apparent dose | Apparent dose of delivered lidocaine assessed by calculating the quantity of lidocaine in the patch as manufactured minus the quantity recovered from the used patch after 12 hours of wear and adhesive residue remaining on skin and on the product liner and envelope | 0 to 12 hours |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Phillip LaStella, MD | TKL Research, Inc. | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32606914 | Derived | Gudin J, Argoff C, Fudin J, Greuber E, Vought K, Patel K, Nalamachu S. A Randomized, Open-Label, Bioequivalence Study of Lidocaine Topical System 1.8% and Lidocaine Patch 5% in Healthy Subjects. J Pain Res. 2020 Jun 22;13:1485-1496. doi: 10.2147/JPR.S237934. eCollection 2020. |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| C511998 | Lidoderm |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Lidocaine patch 5% | Drug |
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| Aniline Compounds |
| D000588 | Amines |