Trial Outcomes & Findings for Three-way Crossover Study Comparing Ondansetron ODFS Administered With and Without Water to Zofran ODT Without Water (NCT NCT01220167)

NCT ID: NCT01220167

Last Updated: 2020-08-18

Results Overview

Maximum Plasma Concentration (Time to reach maximum concentration)

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 18 participants
• Primary outcome timeframe: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
• Results posted on: 2020-08-18

Participant Flow

Fifty-five healthy adult volunteers were screened for study eligibility between 18 Aug 2008 and 21 Aug 2008 at VIMTA VHS Research Centre in Adyar, Chennai - 600 113, India.

Eighteen of 55 subjects were randomized. Of those not randomized, 29 did not meet eligibility criteria and 6 declined to participate. The 18 eligible participants reported to the study site on 22 Aug 2008, 25 Aug 2008 and 28 Aug 2008 for Period 1, Period 2, & Period 3, respectively.

Participant milestones

Measure	Sequence ABC Each subject received a single dose of each of the 3 study treatments in the following order: Test Treatment A (Ondansetron 8 mg ODFS without water), Test Treatment B (Ondansetron 8 mg ODFS with water), Test Treatment C (Zofran ODT containing ondansetron 8 mg without water).	Sequence BCA Each subject received a single dose of each of the 3 study treatments in the following order: Test Treatment B (Ondansetron 8 mg ODFS with water), Test Treatment C (Zofran ODT containing ondansetron 8 mg without water), Test Treatment A (Ondansetron 8 mg ODFS without water).	Sequence CAB Each subject received a single dose of each of the 3 study treatments in the following order: Test Treatment C (Zofran ODT containing ondansetron 8 mg without water), Test Treatment A (Ondansetron 8 mg ODFS without water), Test Treatment B (Ondansetron 8 mg ODFS with water).
Period 1 STARTED	6	6	6
Period 1 COMPLETED	6	6	6
Period 1 NOT COMPLETED	0	0	0
Period 2 STARTED	6	6	6
Period 2 COMPLETED	6	6	6
Period 2 NOT COMPLETED	0	0	0
Period 3 STARTED	6	6	6
Period 3 COMPLETED	6	5	6
Period 3 NOT COMPLETED	0	1	0

Reasons for withdrawal

Measure	Sequence ABC Each subject received a single dose of each of the 3 study treatments in the following order: Test Treatment A (Ondansetron 8 mg ODFS without water), Test Treatment B (Ondansetron 8 mg ODFS with water), Test Treatment C (Zofran ODT containing ondansetron 8 mg without water).	Sequence BCA Each subject received a single dose of each of the 3 study treatments in the following order: Test Treatment B (Ondansetron 8 mg ODFS with water), Test Treatment C (Zofran ODT containing ondansetron 8 mg without water), Test Treatment A (Ondansetron 8 mg ODFS without water).	Sequence CAB Each subject received a single dose of each of the 3 study treatments in the following order: Test Treatment C (Zofran ODT containing ondansetron 8 mg without water), Test Treatment A (Ondansetron 8 mg ODFS without water), Test Treatment B (Ondansetron 8 mg ODFS with water).
Period 3 Urine positive for substance abuse	0	1	0

Baseline Characteristics

Three-way Crossover Study Comparing Ondansetron ODFS Administered With and Without Water to Zofran ODT Without Water

Baseline characteristics by cohort

Measure	Sequence ABC n=6 Participants Each subject received a single dose of each of the 3 study treatments in the following order: Test Treatment A (Ondansetron 8 mg ODFS without water), Test Treatment B (Ondansetron 8 mg ODFS with water), Test Treatment C (Zofran ODT containing ondansetron 8 mg without water).	Sequence BCA n=6 Participants Each subject received a single dose of each of the 3 study treatments in the following order: Test Treatment B (Ondansetron 8 mg ODFS with water), Test Treatment C (Zofran ODT containing ondansetron 8 mg without water), Test Treatment A (Ondansetron 8 mg ODFS without water).	Sequence CAB n=6 Participants Each subject received a single dose of each of the 3 study treatments in the following order: Test Treatment C (Zofran ODT containing ondansetron 8 mg without water), Test Treatment A (Ondansetron 8 mg ODFS without water), Test Treatment B (Ondansetron 8 mg ODFS with water).	Total n=18 Participants Total of all reporting groups
Age, Continuous Age	27.6 years STANDARD_DEVIATION 7.57 • n=5 Participants	31.1 years STANDARD_DEVIATION 8.27 • n=7 Participants	28.8 years STANDARD_DEVIATION 5.98 • n=5 Participants	28.2 years STANDARD_DEVIATION 6.29 • n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	14 Participants n=4 Participants
Body Mass Index (kg/m^2	27.8 kg/m^2 STANDARD_DEVIATION 0.07 • n=5 Participants	22.8 kg/m^2 STANDARD_DEVIATION 0.78 • n=7 Participants	22.9 kg/m^2 STANDARD_DEVIATION 1.95 • n=5 Participants	23.7 kg/m^2 STANDARD_DEVIATION 0.56 • n=4 Participants

PRIMARY outcome

Timeframe: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose

Population: 18 subjects were enrolled. One subject did not complete.

Maximum Plasma Concentration (Time to reach maximum concentration)

Outcome measures

Measure	Ondansetron ODFS With or Without Water and Zofran ODT n=18 Participants Single dose of Ondansetron ODFS 8 mg film administered with and then without water and Zofran 8 mg administered without water
Cmax ODFS without water	40.866 ng/mL Standard Deviation 13.3089
Cmax ODFS with water	42.843 ng/mL Standard Deviation 15.9103
Cmax Zofran ODT	39.382 ng/mL Standard Deviation 12.3572

PRIMARY outcome

Timeframe: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose

Population: 18 healthy subjects were enrolled. Only 17 subjects completed the study. 0 to 96 hours post-dose

Area Under Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (e.g., "0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose")

Outcome measures

Measure	Ondansetron ODFS With or Without Water and Zofran ODT n=17 Participants Single dose of Ondansetron ODFS 8 mg film administered with and then without water and Zofran 8 mg administered without water
AUCt ODFS without water	290.687 ng*hr/mL Standard Deviation 106.5203
AUCt ODFS with water	291.069 ng*hr/mL Standard Deviation 99.5911
AUCt Zofran ODT	285.457 ng*hr/mL Standard Deviation 105.3048

PRIMARY outcome

Timeframe: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose

Population: 18 subject were enrolled. Only 17 completed the study.

Area Under Plasma Concentration-Time Curve From Time Zero to Time Infinity

Outcome measures

Measure	Ondansetron ODFS With or Without Water and Zofran ODT n=17 Participants Single dose of Ondansetron ODFS 8 mg film administered with and then without water and Zofran 8 mg administered without water
AUCinf ODFS without water	311.349 ng*hr/mL Standard Deviation 119.7910
AUCinf ODFS with water	310.394 ng*hr/mL Standard Deviation 112.7499
AUCinf Zofran ODT	306.497 ng*hr/mL Standard Deviation 121.8256

Adverse Events

ODFS 8 mg With and Without Water and Zofran ODT Without Water

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	ODFS 8 mg With and Without Water and Zofran ODT Without Water n=18 participants at risk Single dose of ondansetron ODFS 8 mg film administered with and without water and Zofran 8 mg administered without water in randomized sequence. Clinical laboratory hematology and chemistry tests were performed at screening (pre-study) and at the study follow-up visit (post-study). Thus, abnormal laboratory analytes reported as adverse events could not be attributed to any of the 3 study treatments.
Hepatobiliary disorders Alanine aminotransferase increase	16.7% 3/18 • Number of events 3 • Adverse event data were collected from the time of the first dose until 30 days following the last dose (overall approximately 1.5 months for each subject). No adverse events were reported during the study and follow-up period. Clinical laboratory hematology and chemistry tests were performed at screening (pre-study) and at the study follow-up visit (post-study). Thus, abnormal laboratory analytes reported as adverse events could not be attributed to any of the 3 study treatments. All adverse events (AE) were recorded from the time of the first dose until the last follow-up visit scheduled 48 hours following the last dose of study intervention. Serious adverse events (SAEs) were reported from the time of the first dose until 30 days following the last dose. Subjects with AEs considered related to study drug and any SAE regardless of causality were followed until resolution of the event or the subject was lost to follow-up.
Hepatobiliary disorders Aspartate aminotransferase increased	5.6% 1/18 • Number of events 1 • Adverse event data were collected from the time of the first dose until 30 days following the last dose (overall approximately 1.5 months for each subject). No adverse events were reported during the study and follow-up period. Clinical laboratory hematology and chemistry tests were performed at screening (pre-study) and at the study follow-up visit (post-study). Thus, abnormal laboratory analytes reported as adverse events could not be attributed to any of the 3 study treatments. All adverse events (AE) were recorded from the time of the first dose until the last follow-up visit scheduled 48 hours following the last dose of study intervention. Serious adverse events (SAEs) were reported from the time of the first dose until 30 days following the last dose. Subjects with AEs considered related to study drug and any SAE regardless of causality were followed until resolution of the event or the subject was lost to follow-up.
Investigations White blood count increased	5.6% 1/18 • Number of events 1 • Adverse event data were collected from the time of the first dose until 30 days following the last dose (overall approximately 1.5 months for each subject). No adverse events were reported during the study and follow-up period. Clinical laboratory hematology and chemistry tests were performed at screening (pre-study) and at the study follow-up visit (post-study). Thus, abnormal laboratory analytes reported as adverse events could not be attributed to any of the 3 study treatments. All adverse events (AE) were recorded from the time of the first dose until the last follow-up visit scheduled 48 hours following the last dose of study intervention. Serious adverse events (SAEs) were reported from the time of the first dose until 30 days following the last dose. Subjects with AEs considered related to study drug and any SAE regardless of causality were followed until resolution of the event or the subject was lost to follow-up.

Additional Information

Medical Affairs

Par Pharmaceutical

Phone: 800-828-9393

Email: DrugInfo@strativapharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place