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 U.S. and non-U.S. marketed formulation of ondansetron.
Interventions
DRUGComparator: Treatment A (Zofran, ondansetron)
an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) Zofran taken by mouth (PO)
DRUGComparator: Treatment B (Zofran, ondansetron)
a single 8 mg tablet of Zofran marketed in the U.K., taken PO
DRUGComparator: Treatment C (Zofran, ondansetron)
a single 8 mg tablet of Zofran marketed in the United States (U.S.), taken PO
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 is a nonsmoker * Subject is in good general health
Exclusion criteria
* Subject has a history of high blood pressure, asthma, or cardiovascular, liver, neurologic, or kidney disease * Subject is taking prescription or nonprescription drugs that can not be discontinued during the study * Subject is a habitual and heavy consumer of caffeine
Design outcomes
Primary
| Measure | 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants All randomized participants | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 31.7 years |
| Height | 171.1 centimeters |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 7 Participants |
| Weight | 78.5 kilograms |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 12 | 2 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 12 |
Outcome results
Primary
Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC) of Ondansetron
Time frame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours post dose
Population: All study participants (N=12)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Treatment OE U.K. Tablet | Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC) of Ondansetron | 644 nM*hr | Standard Deviation 240 |
| Treatment U.K. Tablet | Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC) of Ondansetron | 712 nM*hr | Standard Deviation 233 |
| Treatment U.S. Tablet | Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC) of Ondansetron | 649 nM*hr | Standard Deviation 255 |
Comparison: 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 orally95% CI: [0.796, 1.028]
Comparison: 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 orally95% CI: [0.873, 1.126]
Primary
Maximum Plasma Concentration (Cmax) of Ondansetron
Time frame: 24 hours post dose
Population: All study participants (N=12)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Treatment OE U.K. Tablet | Maximum Plasma Concentration (Cmax) of Ondansetron | 82 nM | Standard Deviation 18 |
| Treatment U.K. Tablet | Maximum Plasma Concentration (Cmax) of Ondansetron | 93 nM | Standard Deviation 16 |
| Treatment U.S. Tablet | Maximum Plasma Concentration (Cmax) of Ondansetron | 86 nM | Standard Deviation 20 |
Comparison: 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 orally95% CI: [0.813, 0.966]
Comparison: 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 orally95% CI: [0.872, 1.037]