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

• ClinicalTrials.gov Identifier: NCT01220167
• Recruitment Status: Completed
• First Posted: October 13, 2010
• Results First Posted: August 18, 2020
• Last Update Posted: August 18, 2020
• Sponsor: Aquestive Therapeutics
• Information provided by (Responsible Party): Aquestive Therapeutics

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Healthy Participants
• Interventions: Drug: Ondansetron 8 mg ODFS without water; Drug: Ondansetron 8 mg ODFS with water; Drug: Zofran ODT (ondansetron 8 mg) without water
• Enrollment: 18

Participant Flow

Recruitment Details	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.
Pre-assignment Details	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.

Arm/Group Title	Sequence ABC	Sequence BCA	Sequence CAB
Arm/Group Description	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).	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).	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 Title: Period 1
Started	6	6	6
Completed	6	6	6
Not Completed	0	0	0
Period Title: Period 2
Started	6	6	6
Completed	6	6	6
Not Completed	0	0	0
Period Title: Period 3
Started	6	6	6
Completed	6	5	6
Not Completed	0	1	0
Reason Not Completed
Urine positive for substance abuse	0	1	0

Baseline Characteristics

Arm/Group Title		Sequence ABC	Sequence BCA	Sequence CAB	Total
Arm/Group Description		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).	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).	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 of all reporting groups
Overall Number of Baseline Participants		6	6	6	18
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
Age	Number Analyzed	6 participants	6 participants	6 participants	18 participants
		27.6 (7.57)	31.1 (8.27)	28.8 (5.98)	28.2 (6.29)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	6 participants	6 participants	6 participants	18 participants
	Female	2 33.3%	2 33.3%	0 0.0%	4 22.2%
	Male	4 66.7%	4 66.7%	6 100.0%	14 77.8%
Body Mass Index (kg/m^2; Mean (Standard Deviation); Unit of measure: Kg/m^2
	Number Analyzed	6 participants	6 participants	6 participants	18 participants
		27.8 (0.07)	22.8 (0.78)	22.9 (1.95)	23.7 (0.56)

Outcome Measures

1. Primary Outcome

Title	Cmax
Description	Maximum Plasma Concentration (Time to reach maximum concentration)
Time Frame	0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose

Outcome Measure Data

Analysis Population Description

18 subjects were enrolled. One subject did not complete.

Arm/Group Title		Ondansetron ODFS With or Without Water and Zofran ODT
Arm/Group Description:		Single dose of Ondansetron ODFS 8 mg film administered with and then without water and Zofran 8 mg administered without water
Overall Number of Participants Analyzed		18
Mean (Standard Deviation); Unit of Measure: ng/mL
ODFS without water	Number Analyzed	17 participants
		40.866 (13.3089)
ODFS with water	Number Analyzed	18 participants
		42.843 (15.9103)
Zofran ODT	Number Analyzed	18 participants
		39.382 (12.3572)

2. Primary Outcome

Title	AUCt
Description	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")
Time Frame	0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Ondansetron ODFS With and Without Water and Zofran ODT
Arm/Group Description:	Single dose of Ondansetron ODFS 8 mg film with and again without water and Zofran 8 mg without water
Overall Number of Participants Analyzed	17
Mean (Standard Deviation); Unit of Measure: ng*hr/mL
ODFS without water	290.687 (106.5203)
ODFS with water	291.069 (99.5911)
Zofran ODT	285.457 (105.3048)

3. Primary Outcome

Title	AUCinf
Description	Area Under Plasma Concentration-Time Curve From Time Zero to Time Infinity
Time Frame	0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose

Outcome Measure Data

Analysis Population Description

18 subject were enrolled. Only 17 completed the study.

Arm/Group Title	Ondansetron ODFS With and Without Water and Zofran ODT
Arm/Group Description:	Single dose of Ondansetron ODFS 8 mg film with water and without water and Zofran 8 mg without water
Overall Number of Participants Analyzed	17
Mean (Standard Deviation); Unit of Measure: ng*hr/mL
ODFS without water	311.349 (119.7910)
ODFS with water	310.394 (112.7499)
Zofran ODT	306.497 (121.8256)

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	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.
Arm/Group Title	ODFS 8 mg With and Without Water and Zofran ODT Without Water
Arm/Group Description	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.
All-Cause Mortality
	ODFS 8 mg With and Without Water and Zofran ODT Without Water
	Affected / at Risk (%)
Total	0/18 (0.00%)
Serious Adverse Events
	ODFS 8 mg With and Without Water and Zofran ODT Without Water
	Affected / at Risk (%)	# Events
Total	0/18 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	ODFS 8 mg With and Without Water and Zofran ODT Without Water
	Affected / at Risk (%)	# Events
Total	4/18 (22.22%)
Hepatobiliary disorders
Alanine aminotransferase increase † [1]	3/18 (16.67%)	3
Aspartate aminotransferase increased † [2]	1/18 (5.56%)	1
Investigations
White blood count increased † [3]	1/18 (5.56%)	1
† Indicates events were collected by systematic assessment; [1] ALT increased; [2] AST increased; [3] WBC count increased

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Medical Affairs
• Organization: Par Pharmaceutical
• Phone: 800-828-9393
• EMail: DrugInfo@strativapharma.com

• Responsible Party: Aquestive Therapeutics
• ClinicalTrials.gov Identifier: NCT01220167
• Other Study ID Numbers: OND/CR/051/08/09
• First Submitted: October 12, 2010
• First Posted: October 13, 2010
• Results First Submitted: July 25, 2011
• Results First Posted: August 18, 2020
• Last Update Posted: August 18, 2020