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| ID | Type | Description | Link |
|---|---|---|---|
| MK0869-106 | |||
| 2009_657 |
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This study will assess the bioequivalence of a Merck clinical trial formulation of ondansetron compared to a non-U.S. marketed formulation of ondansetron.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | clinical trial formulation |
|
| B | Active Comparator | non-U.S. marketed formulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ondansetron clinical trial formulation | Drug | Single dose of an over-encapsulated 8 mg tablet of United Kingdom (U.K.) ondansetron (ZOFRAN™) in one of two treatment periods. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Area Under The Concentration Versus Time Curve (AUC(0-infinity)) For Ondansetron | 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours postdose | |
| Peak Plasma Concentration (Cmax) for 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 | Over-encapsulated (OE) United Kingdom (U.K.) tablet then U.K. 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 |
| FG001 | U.K. Tablet Then OE U.K. Tablet | U.K. tablet then OE 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/Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| ||||||||||||||||||
| Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All Randomized Participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Plasma Area Under The Concentration Versus Time Curve (AUC(0-infinity)) For Ondansetron | All 44 of the subjects who completed both Treatments OE U.K. tablet and U.K. tablet were included in the statistical analysis. | Posted | Least Squares Mean | Standard Deviation | ng*hr/mL | 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours postdose |
|
Adverse Events (AEs) were captured from Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 2, 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 | OE U.K. Tablet Then U.K. Tablet | Over-encapsulated (OE) United Kingdom (U.K.) tablet then U.K. 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aborted Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 7.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 7.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
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| 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 |
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|
| ondansetron marketed formulation | Drug | Single dose of an 8 mg tablet of U.K. ondansetron (ZOFRAN™) in one of two treatment periods. |
|
|
| NOT COMPLETED |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Height | Mean | Full Range | Centimeters |
|
| Weight | Mean | Full Range | Killograms |
|
|
|
|
| Primary | Peak Plasma Concentration (Cmax) for Ondansetron | All 44 of the subjects who completed both Treatment OE U.K. tablet and U.K. tablet were included in the statistical analysis. | Posted | Least Squares Mean | Standard Deviation | ng/mL | 24 hours post-dose |
|
|
|
|
| 0 |
| 23 |
| 13 |
| 45 |
| EG001 | U.K. Tablet Then OE U.K. Tablet | U.K. tablet then OE 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/Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally | 1 | 22 | 6 | 44 |
| Nausea | Gastrointestinal disorders | MedDRA 7.1 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 7.1 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA 7.1 | Non-systematic Assessment |
|
| Ear Infection | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 7.1 | Non-systematic Assessment |
|
| Haematocrit Decreased | Investigations | MedDRA 7.1 | Non-systematic Assessment |
|
| Haemoglobin Decreased | Investigations | MedDRA 7.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 7.1 | Non-systematic Assessment |
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| Sinus Headache | Nervous system disorders | MedDRA 7.1 | Non-systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 7.1 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 7.1 | Non-systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA 7.1 | Non-systematic Assessment |
|
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 7.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 7.1 | Non-systematic Assessment |
|
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.
| D002227 |
| Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |