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This study will assess the systemic exposure and pharmacokinetic parameters of SP-103 topical system following one, two, or three topical system applications and compare to the pharmacokinetics of ZTlido.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SP-103 (1 topical system) | Experimental | One topical system applied to the skin on the back for 12 hours. |
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| SP-103 (2 topical systems) | Experimental | Two topical systems applied to the skin on the back for 12 hours. |
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| SP-103 (3 topical systems) | Experimental | Three topical systems applied to the skin on the back for 12 hours. |
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| ZTlido | Active Comparator | Three topical systems applied to the skin on the back for 12 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SP-103 | Drug | lidocaine topical system 5.4% |
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| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration (Cmax) of lidocaine | Peak plasma concentration of lidocaine after 12 hour topical system application | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean adhesion score | Adhesion to skin assessed by FDA 0-4 scoring system. The scoring for adhesion of patches is indicated as follows: 0 = ≥ 90% Adhered (essentially no lift off the skin), 1 = ≥ 75% to < 90% Adhered (some edges only lifting off the skin), 2 = ≥ 50% to < 75% Adhered (less than half of the patch lifting off the skin), > 0% to < 50% Adhered but not detached (more than half of the patch lifting off the skin without falling off), and 4 = 0% adhered (patched completely detached). The mean score is calculated as the average of scores at time 3, 6, 9, and 12 hours. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Boldingh, PharmD | AXIS Clinicals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AXIS Clinicals | Dilworth | Minnesota | 56529 | United States |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| ZTlido | Drug | lidocaine topical system 1.8% |
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| 0, 3, 6, 9, 12 hours post-dose |
| Dermal response score | Product tolerability is assessed by Dermal Response Score. The application site is evaluated 30 minutes and 2 hours after product removal (12.5 and 14 hours post-dose, respectively). Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test (i.e., application) site. | 12.5 and 14 hours post-dose |
| Aniline Compounds |
| D000588 | Amines |