Trial Outcomes & Findings for Crossover Study Comparing Ondansetron Orally Dissolving Film Strip (ODFS) With Zofran Orally Disintegrating Tablets (NCT NCT01217190)

NCT ID: NCT01217190

Last Updated: 2020-07-29

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 48 participants
• Primary outcome timeframe: 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
• Results posted on: 2020-07-29

Participant Flow

The planned sample size was 48. Of the 48 participants enroll in the study, 46 completed the study.

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.

Participant milestones

Measure	Experimental: Ondansetron ODFS, Then Zofran ODT 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.	Experimental: Zofran ODT, Then Ondansetron ODFS 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.
First Dosing STARTED	24	24
First Dosing COMPLETED	24	24
First Dosing NOT COMPLETED	0	0
Second Dosing STARTED	24	24
Second Dosing COMPLETED	24	22
Second Dosing NOT COMPLETED	0	2

Reasons for withdrawal

Measure	Experimental: Ondansetron ODFS, Then Zofran ODT 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.	Experimental: Zofran ODT, Then Ondansetron ODFS 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.
Second Dosing Withdrawal by Subject	0	2

Baseline Characteristics

All 24 who entered Ondansetron ODSF first, then Zofran ODT arm completed both periods. All 24 subjects who entered Zofran ODT first, then Ondansetron ODSF arm completed the first period, 22 of these 24 subjects completed the second period.

Baseline characteristics by cohort

Measure	Experimental: Ondansetron ODFS, Then Zofran ODT n=24 Participants 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.	Experimental: Zofran ODT, Then Ondansetron ODFS n=24 Participants 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 n=48 Participants Total of all reporting groups
Age, Continuous Age	29.7 years STANDARD_DEVIATION 6.08 • n=5 Participants • All 24 who entered Ondansetron ODSF first, then Zofran ODT arm completed both periods. All 24 subjects who entered Zofran ODT first, then Ondansetron ODSF arm completed the first period, 22 of these 24 subjects completed the second period.	28.7 years STANDARD_DEVIATION 5.6 • n=7 Participants • All 24 who entered Ondansetron ODSF first, then Zofran ODT arm completed both periods. All 24 subjects who entered Zofran ODT first, then Ondansetron ODSF arm completed the first period, 22 of these 24 subjects completed the second period.	29.2 years STANDARD_DEVIATION 0.7 • n=5 Participants • All 24 who entered Ondansetron ODSF first, then Zofran ODT arm completed both periods. All 24 subjects who entered Zofran ODT first, then Ondansetron ODSF arm completed the first period, 22 of these 24 subjects completed the second period.
Sex: Female, Male Female	4 Participants n=5 Participants • No subjects dropped out of Organestron ODFS, then Zofran ODT arm. Two subjects dropped out of Zofran ODT, then Oganestron ODFS arm	3 Participants n=7 Participants • No subjects dropped out of Organestron ODFS, then Zofran ODT arm. Two subjects dropped out of Zofran ODT, then Oganestron ODFS arm	7 Participants n=5 Participants • No subjects dropped out of Organestron ODFS, then Zofran ODT arm. Two subjects dropped out of Zofran ODT, then Oganestron ODFS arm
Sex: Female, Male Male	20 Participants n=5 Participants • No subjects dropped out of Organestron ODFS, then Zofran ODT arm. Two subjects dropped out of Zofran ODT, then Oganestron ODFS arm	21 Participants n=7 Participants • No subjects dropped out of Organestron ODFS, then Zofran ODT arm. Two subjects dropped out of Zofran ODT, then Oganestron ODFS arm	41 Participants n=5 Participants • No subjects dropped out of Organestron ODFS, then Zofran ODT arm. Two subjects dropped out of Zofran ODT, then Oganestron ODFS arm
Region of Enrollment India	24 Participants n=5 Participants	24 Participants n=7 Participants	48 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Population: 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).

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

Outcome measures

Measure	Ondansetron ODFS n=46 Participants 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	Zofran ODT n=46 Participants 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
Cmax	37.282 ng/mL Standard Deviation 14.9177	41.108 ng/mL Standard Deviation 17.2442

PRIMARY outcome

Timeframe: 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

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

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

Outcome measures

Measure	Ondansetron ODFS n=46 Participants 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	Zofran ODT n=46 Participants 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
AUCt	216.269 ng*hr/mL Standard Deviation 83.2883	239.463 ng*hr/mL Standard Deviation 100.0745

PRIMARY outcome

Timeframe: 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

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

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

Outcome measures

Measure	Ondansetron ODFS n=46 Participants 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	Zofran ODT n=46 Participants 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
AUCinf	225.032 nghr/mL Standard Deviation 88.2551	250.673 nghr/mL Standard Deviation 107.9654

Adverse Events

Ondansetron ODFS

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Zofran ODT

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ondansetron ODFS n=24 participants at risk 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	Zofran ODT n=22 participants at risk 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
Blood and lymphatic system disorders Eosinophil count increased	4.2% 1/24 • Number of events 1 • Adverse event data were collected over the full course of the study (approximately 1 month for each treatment arm). Safety Population included all participants who received at least 1 dose of study drug.	4.5% 1/22 • Number of events 1 • Adverse event data were collected over the full course of the study (approximately 1 month for each treatment arm). Safety Population included all participants who received at least 1 dose of study drug.
Hepatobiliary disorders Aspartate aminotransferase increased	0.00% 0/24 • Adverse event data were collected over the full course of the study (approximately 1 month for each treatment arm). Safety Population included all participants who received at least 1 dose of study drug.	4.5% 1/22 • Number of events 1 • Adverse event data were collected over the full course of the study (approximately 1 month for each treatment arm). Safety Population included all participants who received at least 1 dose of study drug.
Hepatobiliary disorders Total bilirubin increased	0.00% 0/24 • Adverse event data were collected over the full course of the study (approximately 1 month for each treatment arm). Safety Population included all participants who received at least 1 dose of study drug.	4.5% 1/22 • Number of events 1 • Adverse event data were collected over the full course of the study (approximately 1 month for each treatment arm). Safety Population included all participants who received at least 1 dose of study drug.
Hepatobiliary disorders Alanine aminotransferase increased	8.3% 2/24 • Number of events 2 • Adverse event data were collected over the full course of the study (approximately 1 month for each treatment arm). Safety Population included all participants who received at least 1 dose of study drug.	9.1% 2/22 • Number of events 2 • Adverse event data were collected over the full course of the study (approximately 1 month for each treatment arm). Safety Population included all participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Platelet count decreased	0.00% 0/24 • Adverse event data were collected over the full course of the study (approximately 1 month for each treatment arm). Safety Population included all participants who received at least 1 dose of study drug.	4.5% 1/22 • Number of events 1 • Adverse event data were collected over the full course of the study (approximately 1 month for each treatment arm). Safety Population included all participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Lymphocyte count increased	0.00% 0/24 • Adverse event data were collected over the full course of the study (approximately 1 month for each treatment arm). Safety Population included all participants who received at least 1 dose of study drug.	4.5% 1/22 • Number of events 1 • Adverse event data were collected over the full course of the study (approximately 1 month for each treatment arm). Safety Population included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal Pain	8.3% 2/24 • Number of events 2 • Adverse event data were collected over the full course of the study (approximately 1 month for each treatment arm). Safety Population included all participants who received at least 1 dose of study drug.	0.00% 0/22 • Adverse event data were collected over the full course of the study (approximately 1 month for each treatment arm). Safety Population included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	4.2% 1/24 • Number of events 1 • Adverse event data were collected over the full course of the study (approximately 1 month for each treatment arm). Safety Population included all participants who received at least 1 dose of study drug.	0.00% 0/22 • Adverse event data were collected over the full course of the study (approximately 1 month for each treatment arm). Safety Population included all participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders White blood cell count increased	4.2% 1/24 • Number of events 1 • Adverse event data were collected over the full course of the study (approximately 1 month for each treatment arm). Safety Population included all participants who received at least 1 dose of study drug.	0.00% 0/22 • Adverse event data were collected over the full course of the study (approximately 1 month for each treatment arm). Safety Population included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	4.2% 1/24 • Number of events 1 • Adverse event data were collected over the full course of the study (approximately 1 month for each treatment arm). Safety Population included all participants who received at least 1 dose of study drug.	0.00% 0/22 • Adverse event data were collected over the full course of the study (approximately 1 month for each treatment arm). Safety Population included all participants who received at least 1 dose of study drug.

Additional Information

Medical Affairs

Par Pharmaceutical

Phone: 1-800-828-9393

Email: DrugInfo@strativapharma.com

Results disclosure agreements

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