01905/08-09: Crossover Study Comparing Ondansetron Orally Dissolving Film Strip (ODFS) With Zofran Orally Disintegrating Tablets

• Sponsor: MonoSol Rx (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01217190
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 2
• Actual Duration (Days): 20
• Patients Per Site Per Month: 73.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Nausea and Vomiting, Postoperative; Nausea With Vomiting Chemotherapy-Induced	Drug: Ondansetron (ODFS); Drug: Zofran (ODT)	Phase 1/Phase 2

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Two period study, two treatment, randomized sequenceTwo period study, two treatment, randomized sequence
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: Sep 16, 2008
• Actual Primary Completion Date: Sep 26, 2008
• Actual Study Completion Date: Oct 6, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ondansetron ODFS then Zofran ODT 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	Drug: Ondansetron (ODFS); Test Article; Other Names: Ondansetron Orally Dissolving Film Strip ; Drug: Zofran (ODT); Comparator; Other Names: Zofran Orally Disintegrating Tablet
Experimental: Zofran ODT then Ondansetron ODFS 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	Drug: Ondansetron (ODFS); Test Article; Other Names: Ondansetron Orally Dissolving Film Strip ; Drug: Zofran (ODT); Comparator; Other Names: Zofran Orally Disintegrating Tablet

Outcome Measures

Primary Outcome Measures

1. Cmax [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]

   Maximum Plasma Concentration occurring at Tmax (Time to reach maximum concentration)

2. AUCt [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]

   Area Under Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration

3. AUCinf [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]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VIMTA VHS Research Centre	Adyar	Chennai	India	600 113

Sponsors and Collaborators

• MonoSol Rx

Investigators

• Principal Investigator: Sudershan Vishwanath, MD, Vimta Labs Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: MonoSol Rx
• ClinicalTrials.gov Identifier: NCT01217190
• Other Study ID Numbers: OND/CR/020/08-09; NCT01216969
• First Posted: Oct 8, 2010
• Last Update Posted: Jul 29, 2020
• Last Verified: Jul 1, 2020

• Keywords provided by MonoSol Rx: Bioequivalence, safety, and tolerability
• Additional relevant MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting; Ondansetron

Study Results

Participant Flow

Recruitment Details	The planned sample size was 48. Of the 48 participants enroll in the study, 46 completed the study.
Pre-assignment Detail	A total of 68 volunteers (52 males and 16 females) were screened for enrollment and a total of 48 volunteers (41 males and 7 females) were subsequently admitted to the study.

Arm/Group Title	Experimental: Ondansetron ODFS, Then Zofran ODT	Experimental: Zofran ODT, Then Ondansetron ODFS
Arm/Group Description	Participants first received a single oral dose of Ondansetron Orally Dissolving Film Strip (ODFS) 8 mg after an overnight fast of at least 10 hours. After a washout period of 7 days, they then received a single oral dose of Zofran Orally Disintegrating Tablet (ODT) containing ondansetron 8 mg after an overnight fast of at least 10 hours.	Participants first received a single oral dose of Zofran Orally Disintegrating Tablet (ODT) containing ondansetron 8 mg after an overnight fast of at least 10 hours. After a washout period of 7 days, they then received a single oral dose of Ondansetron Oral Dissolving Film Strip (ODFS) 8 mg after an overnight fast of at least 10 hours.
Period Title: First Dosing
STARTED	24	24
COMPLETED	24	24
NOT COMPLETED	0	0
Period Title: First Dosing
STARTED	24	24
COMPLETED	24	22
NOT COMPLETED	0	2

Baseline Characteristics

Arm/Group Title	Experimental: Ondansetron ODFS, Then Zofran ODT	Experimental: Zofran ODT, Then Ondansetron ODFS	Total
Arm/Group Description	24 participants completed treatment with Ondansetron ODSF 8 mg. After a washout period of 7 days, 24 of the 24 participants who completed the first treatment also completed treatment with Zofran ODT 8mg.	24 participants completed treatment with Zofran ODT 8 mg. After a washout period of 7 days, 22 of the 24 participants who completed the first treatment also completed treatment with Ondansetron ODSF 8 mg	Total of all reporting groups
Overall Participants	24	24	48
Age (years) [Mean (Standard Deviation) ]
Age	29.7 (6.08)	28.7 (5.6)	29.2 (0.7)
Sex: Female, Male (Count of Participants)
Female	4 16.7%	3 12.5%	7 14.6%
Male	20 83.3%	21 87.5%	41 85.4%
Region of Enrollment (Count of Participants)
India	24 100%	24 100%	48 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Pharmacokinetic analysis population comprised all subjects who received study drug in both study periods and completed the study. Two of the 24 subjects in the Zofran ODT then Ondansetron ODSF arm did not return for Period 2 for personal reasons other than adverse events (voluntary withdrawal).

Arm/Group Title	Ondansetron ODFS	Zofran ODT
Arm/Group Description	Single dose of Ondansetron Orally Dissolving Film Strip (ODFS) 8 mg ODFS:Two-way cross-over study to compare ODFS 8 mg with Zofran Orally Disintegrating Table (ODT) containing ondansetron 8 mg	Single dose of Zofran (Ondansetron) Orally Disintegrating Tablet (ODT) containing ondansetron 8 mg Zofran (ODT): Two-way cross-over study to compare ODFS 8 mg with Zofran ODT 8 mg
Measure Participants	46	46
Mean (Standard Deviation) [ng/mL]	37.282 (14.9177)	41.108 (17.2442)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

46 subjects completed both Treatments. 2 subjects did not return for Period 2.

Arm/Group Title	Ondansetron ODFS	Zofran ODT
Arm/Group Description	Single dose of Ondansetron Orally Dissolving Film Strip 8 mg Ondansetron (ODS): Two-wy cross-over study to compare ondansetron ODSF with Zofran ODT	Single dose of Zofran ODT® Orally Disintegrating Tablet 8 mg Zofran (ODT): Two way cross-over study to compare ondansetron ODSF with Zofran ODT
Measure Participants	46	46
Mean (Standard Deviation) [ng*hr/mL]	216.269 (83.2883)	239.463 (100.0745)

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

46 subjects completed both periods. 2 subjects did not complete period 2

Arm/Group Title	Ondansetron ODFS	Zofran ODT
Arm/Group Description	Single dose of Ondansetron Orally Dissolving Film Strip 8 mg Ondansetron (ODS): Two-wy cross-over study to compare ondansetron ODSF with Zofran ODT	Single dose of Zofran (Ondansetron) ODT® Orally Disintegrating Tablets 8 mg Zofran (ODT): Two way cross-over study to compare ondansetron ODSF with Zofran ODT
Measure Participants	46	46
Mean (Standard Deviation) [nghr/mL]	225.032 (88.2551)	250.673 (107.9654)

Adverse Events

Time Frame	Adverse event data were collected over the full course of the study (approximately 1 month for each treatment arm).
Adverse Event Reporting Description	Safety Population included all participants who received at least 1 dose of study drug.
Arm/Group Title	Ondansetron ODFS		Zofran ODT
Arm/Group Description	Single dose of Ondansetron Orally Dissolving Film Strip (ODFS) 8 mg ODFS: Two-way cross-over study to compare ODFS 8 mg with Zofran Orally Disintegrating Tablet (ODT) containing ondansetron 8 mg		Single dose of Zofran Orally Disintegrating Tablet (ODT) containing ondansetron 8 mg Zofran ODT: Two-way cross-over study to compare ODFS 8 mg with Zofran ODT 8 mg
All Cause Mortality
	Ondansetron ODFS		Zofran ODT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/22 (0%)
Serious Adverse Events
	Ondansetron ODFS		Zofran ODT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/22 (0%)
Other (Not Including Serious) Adverse Events
	Ondansetron ODFS		Zofran ODT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/24 (25%)		7/22 (31.8%)
Blood and lymphatic system disorders
Eosinophil count increased	1/24 (4.2%)	1	1/22 (4.5%)	1
Platelet count decreased	0/24 (0%)	0	1/22 (4.5%)	1
Lymphocyte count increased	0/24 (0%)	0	1/22 (4.5%)	1
White blood cell count increased	1/24 (4.2%)	1	0/22 (0%)	0
Gastrointestinal disorders
Abdominal Pain	2/24 (8.3%)	2	0/22 (0%)	0
Vomiting	1/24 (4.2%)	1	0/22 (0%)	0
Hepatobiliary disorders
Aspartate aminotransferase increased	0/24 (0%)	0	1/22 (4.5%)	1
Alanine aminotransferase increased	2/24 (8.3%)	2	2/22 (9.1%)	2
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection	1/24 (4.2%)	1	0/22 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.