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This was an open-label, balanced, two-treatment, two-period, randomized sequence crossover bioequivalence study with a 7-day washout between periods. Each treatment was administered after an overnight (10 hours) fast.
This was an open label, balanced, randomized, two-treatment, two-period, randomized sequence crossover study conducted in healthy adult male and female volunteers. Subjects checked into the study center on Day -1 of each study period at least 12 hours prior to dosing on Day 1. Subjects were served dinner between 8:00 pm to 8:30 pm to ensure minimum 10 hours fast prior to dosing in both periods. Subjects received the 2 treatments in a randomized order with a 7-day washout between the 2 periods.
Treatment A: single dose of ondansetron ODFS 8 mg was orally administered, allowed to dissolve, swallowed with saliva, followed with 240 mL room temperature drinking water
Treatment B: single dose of Zofran ODT (containing ondansetron 8 mg) was orally administered, allowed to dissolve, swallowed with saliva, followed with 240 mL room temperature drinking water
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ondansetron ODFS then Zofran ODT | Experimental | Single dose of Ondansetron Orally Dissolving Film Strip 8 mg followed by single dose of Zofran ODT® Orally Disintegrating Tablet containing Ondansetron 8 mg with 7 days washout between the 2 periods |
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| Zofran ODT then Ondansetron ODFS | Experimental | Single dose of Zofran ODT® Orally Disintegrating Tablet containing Ondansetron 8 mg followed by single dose of Ondansetron Orally Dissolving Film Strip 8 mg with 7 days washout between the 2 periods |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ondansetron (ODFS) | Drug | Test Article |
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| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum Plasma Concentration occurring at Tmax (Time to reach maximum concentration) | 0,0.33,0.67,1,1.33,1.67,2,2.33,2.67,3,4,6,8,10,12,15,18,24 hours |
| AUCt | Area Under Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration | 0,0.33,0.67,1,1.33,1.67,2,2.33,2.67,3,4,6,8,10,12,15,18,24 hours |
| AUCinf | Area Under Plasma Concentration-Time Curve From Time Zero to Time Infinity | 0,0.33,0.67,1,1.33,1.67,2,2.33,2.67,3,4,6,8,10,12,15,18,24 hours |
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Inclusion Criteria:
Criteria: Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sudershan Vishwanath, MD | Vimta Labs Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VIMTA VHS Research Centre | Adyār | Chennai | 600 113 | India |
A total of 68 volunteers (52 males and 16 females) were screened for enrollment and a total of 48 volunteers (41 males and 7 females) were subsequently admitted to the study.
The planned sample size was 48. Of the 48 participants enroll in the study, 46 completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: Ondansetron ODFS, Then Zofran ODT | Participants first received a single oral dose of Ondansetron Orally Dissolving Film Strip (ODFS) 8 mg after an overnight fast of at least 10 hours. After a washout period of 7 days, they then received a single oral dose of Zofran Orally Disintegrating Tablet (ODT) containing ondansetron 8 mg after an overnight fast of at least 10 hours. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Dosing |
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Two period study, two treatment, randomized sequence
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| Zofran (ODT) | Drug | Comparator |
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| FG001 | Experimental: Zofran ODT, Then Ondansetron ODFS | Participants first received a single oral dose of Zofran Orally Disintegrating Tablet (ODT) containing ondansetron 8 mg after an overnight fast of at least 10 hours. After a washout period of 7 days, they then received a single oral dose of Ondansetron Oral Dissolving Film Strip (ODFS) 8 mg after an overnight fast of at least 10 hours. |
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| NOT COMPLETED |
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| Second Dosing |
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A total of 48 subjects were entered into the study. Two did not complete.
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: Ondansetron ODFS, Then Zofran ODT | 24 participants completed treatment with Ondansetron ODSF 8 mg. After a washout period of 7 days, 24 of the 24 participants who completed the first treatment also completed treatment with Zofran ODT 8mg. |
| BG001 | Experimental: Zofran ODT, Then Ondansetron ODFS | 24 participants completed treatment with Zofran ODT 8 mg. After a washout period of 7 days, 22 of the 24 participants who completed the first treatment also completed treatment with Ondansetron ODSF 8 mg |
| BG002 | Total | Total of all reporting groups |
| 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, Continuous | All 24 who entered Ondansetron ODSF first, then Zofran ODT arm completed both periods. All 24 subjects who entered Zofran ODT first, then Ondansetron ODSF arm completed the first period, 22 of these 24 subjects completed the second period. | Mean | Standard Deviation | years |
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| Sex: Female, Male | No subjects dropped out of Organestron ODFS, then Zofran ODT arm. Two subjects dropped out of Zofran ODT, then Oganestron ODFS arm | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 Plasma Concentration occurring at Tmax (Time to reach maximum concentration) | Pharmacokinetic analysis population comprised all subjects who received study drug in both study periods and completed the study. Two of the 24 subjects in the Zofran ODT then Ondansetron ODSF arm did not return for Period 2 for personal reasons other than adverse events (voluntary withdrawal). | Posted | Mean | Standard Deviation | ng/mL | 0,0.33,0.67,1,1.33,1.67,2,2.33,2.67,3,4,6,8,10,12,15,18,24 hours |
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| Primary | AUCt | Area Under Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration | 46 subjects completed both Treatments. 2 subjects did not return for Period 2. | Posted | Mean | Standard Deviation | ng*hr/mL | 0,0.33,0.67,1,1.33,1.67,2,2.33,2.67,3,4,6,8,10,12,15,18,24 hours |
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| Primary | AUCinf | Area Under Plasma Concentration-Time Curve From Time Zero to Time Infinity | 46 subjects completed both periods. 2 subjects did not complete period 2 | Posted | Mean | Standard Deviation | nghr/mL | 0,0.33,0.67,1,1.33,1.67,2,2.33,2.67,3,4,6,8,10,12,15,18,24 hours |
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Adverse event data were collected over the full course of the study (approximately 1 month for each treatment arm).
Safety Population included all participants who received at least 1 dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ondansetron ODFS | Single dose of Ondansetron Orally Dissolving Film Strip (ODFS) 8 mg ODFS: Two-way cross-over study to compare ODFS 8 mg with Zofran Orally Disintegrating Tablet (ODT) containing ondansetron 8 mg | 0 | 24 | 0 | 24 | 6 | 24 |
| EG001 | Zofran ODT | Single dose of Zofran Orally Disintegrating Tablet (ODT) containing ondansetron 8 mg Zofran ODT: Two-way cross-over study to compare ODFS 8 mg with Zofran ODT 8 mg | 0 | 22 | 0 | 22 | 7 | 22 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eosinophil count increased | Blood and lymphatic system disorders | Systematic Assessment | Increased eosinophil count |
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| Aspartate aminotransferase increased | Hepatobiliary disorders | Systematic Assessment | Increased AST |
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| Total bilirubin increased | Hepatobiliary disorders | Systematic Assessment | Increased total bilirubin |
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| Alanine aminotransferase increased | Hepatobiliary disorders | Systematic Assessment | Increased ALT |
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| Platelet count decreased | Blood and lymphatic system disorders | Systematic Assessment | Decreased platelet count |
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| Lymphocyte count increased | Blood and lymphatic system disorders | Systematic Assessment | Increased lymphocyte count |
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| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| White blood cell count increased | Blood and lymphatic system disorders | Systematic Assessment | WBC count increased |
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| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Upper respiratory tract infection |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Affairs | Par Pharmaceutical | 1-800-828-9393 | DrugInfo@strativapharma.com |
| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
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| ID | Term |
|---|---|
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
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