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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_656 |
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This study will assess the bioequivalence of a Merck clinical trial formulation of ondansetron compared to a U.S. and non-U.S. marketed formulation of ondansetron.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Treatment Sequence A-B-C |
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| 2 | Experimental | Treatment Sequence B-C-A |
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| 3 | Experimental | Treatment Sequence C-A-B |
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| 4 | Experimental | Treatment Sequence A-C-B |
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| 5 | Experimental | Treatment Sequence B-A-C |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: Treatment A (Zofran, ondansetron) | Drug | an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) Zofran taken by mouth (PO) |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC) of Ondansetron | 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours post dose | |
| Maximum Plasma Concentration (Cmax) of Ondansetron | 24 hours post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | OE U.K. Tablet Then U.K. Tablet Then U.S. Tablet | Over-encapsulated (OE) United Kingdom (U.K.) tablet then U.K. tablet then United States (U.S.) tablet: Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally./Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally./Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
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| 6 | Experimental | Treatment Sequence C-B-A |
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| Comparator: Treatment B (Zofran, ondansetron) | Drug | a single 8 mg tablet of Zofran marketed in the U.K., taken PO |
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| Comparator: Treatment C (Zofran, ondansetron) | Drug | a single 8 mg tablet of Zofran marketed in the United States (U.S.), taken PO |
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| FG001 | U.K. Tablet Then U.S. Tablet Then OE U.K. Tablet | U.K. tablet then U.S. tablet then OE U.K. tablet: Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.K. taken orally /Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of U.K. ZOFRAN (ondansetron) taken orally. |
| FG002 | U.S. Tablet Then OE U.K. Tablet Then U.K. Tablet | U.S. tablet then OE U.K. tablet then U.K. tablet: Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of U.K ZOFRAN (ondansetron) taken orally/Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.K. taken orally |
| FG003 | OE U.K. Tablet Then U.S. Tablet Then U.K. Tablet | OE U.K. tablet then U.S. tablet then U.K. tablet: Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of U.K. ZOFRAN (ondansetron) taken orally/Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally/Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.K. taken orally |
| FG004 | U.K. Tablet Then OE U.K. Tablet Then U.S. Tablet | U.K. tablet then OE U.K. tablet then U.S. tablet: Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.K. taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of U.K. ZOFRAN (ondansetron) taken orally/Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally |
| FG005 | U.S. Tablet Then U.K. Tablet Then OE U.K. Tablet | U.S. tablet then U.K. tablet then OE U.K. tablet: Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally/Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.K. taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of U.K. ZOFRAN (ondansetron) taken orally |
| COMPLETED |
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| NOT COMPLETED |
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| Period 2 |
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| Period 3 |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All randomized participants |
| 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 | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Weight | Mean | Full Range | kilograms |
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| Height | Mean | Full Range | centimeters |
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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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC) of Ondansetron | All study participants (N=12) | Posted | Least Squares Mean | Standard Deviation | nM*hr | 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours post dose |
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| Primary | Maximum Plasma Concentration (Cmax) of Ondansetron | All study participants (N=12) | Posted | Least Squares Mean | Standard Deviation | nM | 24 hours post dose |
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Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 3, including the 7 day washout in between periods.
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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 | Treatment OE U.K. Tablet | Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally | 0 | 12 | 0 | 12 | ||
| EG001 | Treatment U.K. Tablet | Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally | 0 | 12 | 0 | 12 | ||
| EG002 | Treatment U.S. Tablet | Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United States (U.S.) taken orally | 0 | 12 | 2 | 12 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
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Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Vice President, Clinical and Quantitative Sciences | Merck Sharp & Dohme Corp | 1-800-672-6372 |
| ID | Term |
|---|---|
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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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| Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United States (U.S.) taken orally | Geometric Mean Ratio | 0.991 | 2-Sided | 95 | 0.873 | 1.126 | Geometric Mean Ratio (Treatment OE U.K. tablet / Treatment U.S. tablet) | Yes | Non-Inferiority or Equivalence | Study Primary Hypothesis: A single dose of the U.K. ZOFRAN (ondansetron) 8-mg tablet over-encapsulated is bioequivalent to a single dose of the U.S. ZOFRAN (ondansetron) 8-mg tablet. That is, the true geometric mean rations (U.K. ZOFRAN tablet over-encapsulated/U.S. ZOFRAN tablet) of the area under the plasma concentration vs. time curve (AUC) from zero to infinity and maximum plasma concentration (Cmax) for ondansetron each lie within the interval 0.80 to 1.25. |
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