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Trial record 7 of 7 for:    aquestive

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

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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:
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
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
Hide 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
Arm/Group Title Sequence ABC Sequence BCA Sequence CAB Total
Hide 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
Hide 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)
1.Primary Outcome
Title Cmax
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
18 subjects were enrolled. One subject did not complete.
Arm/Group Title Ondansetron ODFS With or Without Water and Zofran ODT
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
18 subject were enrolled. Only 17 completed the study.
Arm/Group Title Ondansetron ODFS With and Without Water and Zofran ODT
Hide 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)
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
Hide 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%)    
Hide Serious Adverse Events
ODFS 8 mg With and Without Water and Zofran ODT Without Water
Affected / at Risk (%) # Events
Total   0/18 (0.00%)    
Hide 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
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Affairs
Organization: Par Pharmaceutical
Phone: 800-828-9393
EMail: DrugInfo@strativapharma.com
Layout table for additonal information
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