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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: a bolus IV injection of 0.7 mg/kg lidocaine IV in the morning of study Day 1, and then lidocaine patch treatment on Day 8 and Day 15. The sequence in which they received patch treatment was determined by random assignment. For subjects in Arm 1, 3 lidocaine 1.8% patches were applied on Day 8 and 3 Lidoderm® 5% patches were applied on Day 15. |
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| Lidocaine Patch (Sequence BA) | Experimental | Subjects received all study treatments: a bolus IV injection of 0.7 mg/kg lidocaine IV in the morning of study Day 1, and then lidocaine patch treatment on Day 8 and Day 15. The sequence in which they received patch treatment was determined by random assignment. For subjects in Arm 2, 3 Lidoderm® 5% patches were applied on Day 8 and 3 lidocaine 1.8% patches were applied on Day 15. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine patch 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 plasma | 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose |
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Inclusion Criteria:
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 |
| D057968 | Transdermal Patch |
| C511998 | Lidoderm |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Lidocaine 5% patch | Drug |
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| Lidocaine 2% Injectable Solution | Drug |
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| Aniline Compounds |
| D000588 | Amines |
| D004864 | Equipment and Supplies |