Chemotherapy-Induced Nausea and Vomiting
Conditions
Brief summary
This study will assess the bioequivalence of a Merck clinical trial formulation of ondansetron compared to a non-U.S. marketed formulation of ondansetron.
Interventions
DRUGondansetron clinical trial formulation
Single dose of an over-encapsulated 8 mg tablet of United Kingdom (U.K.) ondansetron (ZOFRAN™) in one of two treatment periods.
DRUGondansetron marketed formulation
Single dose of an 8 mg tablet of U.K. ondansetron (ZOFRAN™) in one of two treatment periods.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* If female, subject is not pregnant or breast-feeding * Subject has been a nonsmoker for at least 6 months * Subject is in good health
Exclusion criteria
* Subject has a history of high blood pressure, asthma, other pulmonary disease, Gastrointestinal (GI) abnormalities/peptic ulcers, or cardiovascular, liver, neurologic, or kidney disease * Subject is a habitual and heavy consumer of caffeine
Design outcomes
Primary
| Measure | 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants All Randomized Participants | 45 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Adverse Event | 1 | 0 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 34 Years |
| Height | 170.8 Centimeters |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 19 Participants |
| Weight | 72.0 Killograms |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 45 | 6 / 44 |
| serious Total, serious adverse events | 0 / 23 | 1 / 22 |
Outcome results
Primary
Peak Plasma Concentration (Cmax) for Ondansetron
Time frame: 24 hours post-dose
Population: All 44 of the subjects who completed both Treatment OE U.K. tablet and U.K. tablet were included in the statistical analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| OE U.K. Tablet | Peak Plasma Concentration (Cmax) for Ondansetron | 41.3 ng/mL | Standard Deviation 13.7 |
| U.K. Tablet | Peak Plasma Concentration (Cmax) for Ondansetron | 41.8 ng/mL | Standard Deviation 13.6 |
Comparison: Least-Squares Mean Ratio (OE U.K. tablet / U.K. tablet): an over-encapsulated single 8 mg tablet of United Kingdom~(U.K.) ZOFRAN™ (ondansetron) taken orally; a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the~United Kingdom (U.K.) taken orally90% CI: [0.93, 1.05]
Primary
Plasma Area Under The Concentration Versus Time Curve (AUC(0-infinity)) For Ondansetron
Time frame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours postdose
Population: All 44 of the subjects who completed both Treatments OE U.K. tablet and U.K. tablet were included in the statistical analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| OE U.K. Tablet | Plasma Area Under The Concentration Versus Time Curve (AUC(0-infinity)) For Ondansetron | 257.8 ng*hr/mL | Standard Deviation 106.8 |
| U.K. Tablet | Plasma Area Under The Concentration Versus Time Curve (AUC(0-infinity)) For Ondansetron | 262.6 ng*hr/mL | Standard Deviation 105.6 |
Comparison: Least-Squares Mean Ratio (OE U.K. tablet / U.K. tablet): an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally; a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally90% CI: [0.93, 1.03]