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The objective of this study is to compare the relative bioavailability of zaleplon 10 mg capsules(manufactured and distributed by TEVA Pharmaceuticals USA) with that of SONATA® 10mg capsules (Wyeth-Ayerst Pharmaceuticals) in healthy, non-smoking, adult subjects under non-fasting conditions.
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zaleplon | Experimental | Zaleplon 10 mg Capsule (test) dosed in first period followed by Sonata® 10 mg Capsule (reference) dosed in second period |
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| Sonata® | Active Comparator | Sonata® 10 mg Capsule (reference) dosed in first period followed by Zaleplon 10 mg Capsule (test) dosed in second period |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zaleplon 10 mg Capsules | Drug | 1 x 10 mg |
| |
| SONATA® 10 mg capsules |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax - Maximum Observed Concentration | Bioequivalence based on Cmax | Blood samples collected over 12 hour period |
| AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) | Bioequivalence based on AUC0-inf | Blood samples collected over 12 hour period |
| AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) | Bioequivalence based on AUC0-t | Blood samples collected over 12 hour period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| So Ran Hong, M.D. | Novum Pharmaceuticals Research Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novum Pharmaceutical Research Services | Houston | Texas | 77042-4712 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Zaleplon (Test) First | Zaleplon 10 mg Capsule (test) dosed in first period followed by Sonata® 10 mg Capsule (reference) dosed in second period |
| FG001 | Sonata® (Reference) First | Sonata® 10 mg Capsule (reference) dosed in first period followed by Zaleplon 10 mg Capsule (test) dosed in second period |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Washout |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Zaleplon (Test) First | Zaleplon 10 mg Capsule (test) dosed in first period followed by Sonata® 10 mg Capsule (reference) dosed in second period |
| BG001 | Sonata® (Reference) First |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cmax - Maximum Observed Concentration | Bioequivalence based on Cmax | Data from all subjects who completed the study were included in the statistical analysis. | Posted | Jul 2009 | Mean | Standard Deviation | ng/mL | Blood samples collected over 12 hour period |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager, Biopharmaceutics | Teva Pharmaceuticals USA | 1-866-384-5525 | clinicaltrialqueries@tevausa.com |
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| ID | Term |
|---|---|
| C085665 | zaleplon |
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| Drug |
1 x 10 mg |
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| NOT COMPLETED |
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| NOT COMPLETED |
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Sonata® 10 mg Capsule (reference) dosed in first period followed by Zaleplon 10 mg Capsule (test) dosed in second period
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
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| Participants |
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| Primary | AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) | Bioequivalence based on AUC0-inf | Data from all subjects who completed the study were included in the statistical analysis. | Posted | Jul 2009 | Mean | Standard Deviation | ng*h/mL | Blood samples collected over 12 hour period |
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| Primary | AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) | Bioequivalence based on AUC0-t | Data from all subjects who completed the study were included in the statistical analysis. | Posted | Jul 2009 | Mean | Standard Deviation | ng*h/mL | Blood samples collected over 12 hour period |
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Principal Investigator is not permitted to discuss or publish trial results.