Back to resultsCrossover Study Comparing Ondansetron Orally Dissolving Film Strip (ODFS) With Zofran Orally Disintegrating Tablets (01905/08-09)
Primary Purpose
Nausea and Vomiting, Postoperative, Nausea With Vomiting Chemotherapy-Induced
Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Ondansetron (ODFS)
Zofran (ODT)
Sponsored by
About this trial
This is an interventional other trial for Nausea and Vomiting, Postoperative focused on measuring Bioequivalence, safety, and tolerability
Eligibility Criteria
Inclusion Criteria:
- Volunteer should have written informed consent.
- Volunteer healthy adult within 18-45 years of age (inclusive).
- Body mass index of 18.5 kg/m^2 and 25 kg/m^2, body weight not less than 50 kg.
- Volunteer must be of normal health.
- Volunteer should have a normal ECG, chest X-ray and vital signs.
- If study volunteer is a female and is of child bearing potential practicing an acceptable method of birth control for the duration of the study.
Criteria: Exclusion Criteria:
- Volunteer doesn't understand the informed consent.
- Volunteer with a history of hypersensitivity or idiosyncratic reaction to study drug or any other related drug.
- Volunteer having any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function, by standard laboratory, imaging or monitoring procedures
- Volunteer who smokes regularly, alcohol or drug abuse
- Volunteer who has taken over the counter or prescribed medications
- Volunteer with clinically significant abnormal values of laboratory parameters.
- Volunteer who has participated in any other clinical investigation using experimental drug or had bled more than 350 mL in the past 3 months.
- Female volunteer demonstrating a positive pregnancy screen with urine pregnancy test (strip method).
Sites / Locations
- VIMTA VHS Research Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Ondansetron ODFS then Zofran ODT
Zofran ODT then Ondansetron ODFS
Arm Description
Single dose of Ondansetron Orally Dissolving Film Strip 8 mg followed by single dose of Zofran ODT® Orally Disintegrating Tablet containing Ondansetron 8 mg with 7 days washout between the 2 periods
Single dose of Zofran ODT® Orally Disintegrating Tablet containing Ondansetron 8 mg followed by single dose of Ondansetron Orally Dissolving Film Strip 8 mg with 7 days washout between the 2 periods
Outcomes
Primary Outcome Measures
Cmax
Maximum Plasma Concentration occurring at Tmax (Time to reach maximum concentration)
AUCt
Area Under Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration
AUCinf
Area Under Plasma Concentration-Time Curve From Time Zero to Time Infinity
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01217190
Brief Title
Crossover Study Comparing Ondansetron Orally Dissolving Film Strip (ODFS) With Zofran Orally Disintegrating Tablets
Acronym
01905/08-09
Official Title
Open-Label Randomized, Single Oral Dose, Two-Way Crossover Bioequivalence Study Comparing Ondansetron Orally Dissolving Film Strip 8 mg With Zofran Orally Disintegrating Tablets (ODT) (Containing Ondansetron 8 mg) in Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 16, 2008 (Actual)
Primary Completion Date
September 26, 2008 (Actual)
Study Completion Date
October 6, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MonoSol Rx
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This was an open-label, balanced, two-treatment, two-period, randomized sequence crossover bioequivalence study with a 7-day washout between periods. Each treatment was administered after an overnight (10 hours) fast.
Detailed Description
This was an open label, balanced, randomized, two-treatment, two-period, randomized sequence crossover study conducted in healthy adult male and female volunteers. Subjects checked into the study center on Day -1 of each study period at least 12 hours prior to dosing on Day 1. Subjects were served dinner between 8:00 pm to 8:30 pm to ensure minimum 10 hours fast prior to dosing in both periods. Subjects received the 2 treatments in a randomized order with a 7-day washout between the 2 periods.
Treatment A: single dose of ondansetron ODFS 8 mg was orally administered, allowed to dissolve, swallowed with saliva, followed with 240 mL room temperature drinking water
Treatment B: single dose of Zofran ODT (containing ondansetron 8 mg) was orally administered, allowed to dissolve, swallowed with saliva, followed with 240 mL room temperature drinking water
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea and Vomiting, Postoperative, Nausea With Vomiting Chemotherapy-Induced
Keywords
Bioequivalence, safety, and tolerability
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Model Description
Two period study, two treatment, randomized sequence
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ondansetron ODFS then Zofran ODT
Arm Type
Experimental
Arm Description
Single dose of Ondansetron Orally Dissolving Film Strip 8 mg followed by single dose of Zofran ODT® Orally Disintegrating Tablet containing Ondansetron 8 mg with 7 days washout between the 2 periods
Arm Title
Zofran ODT then Ondansetron ODFS
Arm Type
Experimental
Arm Description
Single dose of Zofran ODT® Orally Disintegrating Tablet containing Ondansetron 8 mg followed by single dose of Ondansetron Orally Dissolving Film Strip 8 mg with 7 days washout between the 2 periods
Intervention Type
Drug
Intervention Name(s)
Ondansetron (ODFS)
Other Intervention Name(s)
Ondansetron Orally Dissolving Film Strip
Intervention Description
Test Article
Intervention Type
Drug
Intervention Name(s)
Zofran (ODT)
Other Intervention Name(s)
Zofran Orally Disintegrating Tablet
Intervention Description
Comparator
Primary Outcome Measure Information:
Title
Cmax
Description
Maximum Plasma Concentration occurring at Tmax (Time to reach maximum concentration)
Time Frame
0,0.33,0.67,1,1.33,1.67,2,2.33,2.67,3,4,6,8,10,12,15,18,24 hours
Title
AUCt
Description
Area Under Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration
Time Frame
0,0.33,0.67,1,1.33,1.67,2,2.33,2.67,3,4,6,8,10,12,15,18,24 hours
Title
AUCinf
Description
Area Under Plasma Concentration-Time Curve From Time Zero to Time Infinity
Time Frame
0,0.33,0.67,1,1.33,1.67,2,2.33,2.67,3,4,6,8,10,12,15,18,24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Volunteer should have written informed consent.
Volunteer healthy adult within 18-45 years of age (inclusive).
Body mass index of 18.5 kg/m^2 and 25 kg/m^2, body weight not less than 50 kg.
Volunteer must be of normal health.
Volunteer should have a normal ECG, chest X-ray and vital signs.
If study volunteer is a female and is of child bearing potential practicing an acceptable method of birth control for the duration of the study.
Criteria: Exclusion Criteria:
Volunteer doesn't understand the informed consent.
Volunteer with a history of hypersensitivity or idiosyncratic reaction to study drug or any other related drug.
Volunteer having any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function, by standard laboratory, imaging or monitoring procedures
Volunteer who smokes regularly, alcohol or drug abuse
Volunteer who has taken over the counter or prescribed medications
Volunteer with clinically significant abnormal values of laboratory parameters.
Volunteer who has participated in any other clinical investigation using experimental drug or had bled more than 350 mL in the past 3 months.
Female volunteer demonstrating a positive pregnancy screen with urine pregnancy test (strip method).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sudershan Vishwanath, MD
Organizational Affiliation
Vimta Labs Ltd.
Official's Role
Principal Investigator
Facility Information:
Facility Name
VIMTA VHS Research Centre
City
Adyar
State/Province
Chennai
ZIP/Postal Code
600 113
Country
India
12. IPD Sharing Statement
Learn more about this trial
Crossover Study Comparing Ondansetron Orally Dissolving Film Strip (ODFS) With Zofran Orally Disintegrating Tablets
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