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This study evaluates the relative bioavailability of Acetylcysteine Effervescent Tablets (AR10) and Reference N-acetylcysteine. Patients will receive both products in an Open Label, Randomized, Two-Arm, Single-Dose, Two-Period, Crossover design.
An Open Label, Randomized, Two-Arm, Single-Dose, Two-Period, Crossover Study Relative Bioavailability Study. The present study is intended to compare and evaluate the relative bioavailability of a single 11 gram dose of AR10 (acetylcysteine effervescent tablets for oral solution (two 0.5 g and four 2.5 g]), and the reference Listed Drug (acetylcysteine solution; oral 20% [200 mg/mL] of American Pharmaceutical Partners) in healthy adult, human subjects under fasting conditions. A balanced block randomization schedule will be generated before the start of dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AR10 | Experimental | AR10 acetylcysteine effervescent tablets for oral solution (two 0.5 g and four 2.5 g) |
|
| acetylcysteine | Active Comparator | acetylcysteine solution; oral 20% (200 mg/mL) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AR10 | Drug | effervescent tablet |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Area Under the Curve (AUC) profiles of the two formulations of acetylcysteine to determine the Relative Bioavailability | To compare AUC of a single 11 gram dose of AR10 acetylcysteine effervescent tablets for oral solution (two 0.5 g and four 2.5 g), and the Reference Listed Drug (acetylcysteine solution; oral 20% [200 mg/mL] from American Pharmaceutical Partners) in a minimum of 24 healthy adult, human subjects under fasting conditions, to establish relative bioavailability. | 10 days |
| Comparison of Maximum Plasma Concentration (Cmax) profiles of the two formulations of acetylcysteine to determine the Relative Bioavailability | To compare Cmax of a single 11 gram dose of AR10 acetylcysteine effervescent tablets for oral solution (two 0.5 g and four 2.5 g), and the Reference Listed Drug (acetylcysteine solution; oral 20% [200 mg/mL] from American Pharmaceutical Partners) in a minimum of 24 healthy adult, human subjects under fasting conditions, to establish relative bioavailability. | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| The safety and tolerability of AR10 and the reference product, as measured by treatment-emergent adverse events (AEs), concomitant medications, vital signs (pulse, temperature and respiratory rate), and assessment of well-being. | To compare the safety and tolerability of AR10 and the reference product, as measured by treatment-emergent adverse events (AEs), concomitant medications, vital signs (pulse, temperature and respiratory rate), and assessment of well-being. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of subject preference between AR10 and the reference product using the adapted British Nutritional Foundation's Sensory Evaluation (2004) 5-point hedonic scale. | Following each dose, subjects were asked to rate the taste, smell, flavor, texture, and overall preference of each product using the adapted British Nutritional Foundation's Sensory Evaluation (2004) 5-point hedonic scale, ranging from dislike very much to like very much. After the second dose was taken, subjects were also asked to choose which treatment they would prefer. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tania D Johnson, RN, BSN | Arbor Pharmaceuticals | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27668024 | Derived | Greene SC, Noonan PK, Sanabria C, Peacock WF. Effervescent N-Acetylcysteine Tablets versus Oral Solution N-Acetylcysteine in Fasting Healthy Adults: An Open-Label, Randomized, Single-Dose, Crossover, Relative Bioavailability Study. Curr Ther Res Clin Exp. 2016 Jun 27;83:1-7. doi: 10.1016/j.curtheres.2016.06.001. eCollection 2016. |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| acetylcysteine |
| Drug |
oral solution |
|
|
| 12 days |
| 10 days |
| Evaluation of healthcare provider preference between AR10 and the reference product using the adapted British Nutritional Foundation's Sensory Evaluation (2004) 5-point hedonic scale | Healthcare providers involved in dispensing, preparing, and administering the study drug responded to the preference survey within 30 minutes of completing dosing activities in each study period. | 10 days |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |