Trial Outcomes & Findings for Ondansetron HCl Orally Disintegrating Tablets Under Non-Fasting Conditions (NCT NCT00934921)

NCT ID: NCT00934921

Last Updated: 2024-08-21

Results Overview

Bioequivalence based on Cmax

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 24 participants
• Primary outcome timeframe: Blood samples collected over 24 hour period
• Results posted on: 2024-08-21

Participant Flow

Participant milestones

Measure	Ondansetron (Test) First Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in first period followed by Zofran® 8 mg ODT (reference) dosed in second period	Zofran® (Reference) First Zofran® 8 mg ODT (reference) dosed in first period followed by Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in second period
First Intervention STARTED	12	12
First Intervention COMPLETED	12	12
First Intervention NOT COMPLETED	0	0
Second Intervention STARTED	12	12
Second Intervention COMPLETED	12	12
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ondansetron HCl Orally Disintegrating Tablets Under Non-Fasting Conditions

Baseline characteristics by cohort

Measure	Ondansetron (Test) First n=12 Participants Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in first period followed by Zofran® 8 mg ODT (reference) dosed in second period	Zofran® (Reference) First n=12 Participants Zofran® 8 mg ODT (reference) dosed in first period followed by Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in second period	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Black	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Biracial	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants

PRIMARY outcome

Timeframe: Blood samples collected over 24 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Bioequivalence based on Cmax

Outcome measures

Measure	Ondansetron n=24 Participants Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in either period	Zofran® n=24 Participants Zofran® 8 mg ODT (reference) dosed in either period
Cmax - Maximum Observed Concentration	30.196 ng/mL Standard Deviation 13.378	30.892 ng/mL Standard Deviation 12.653

PRIMARY outcome

Timeframe: Blood samples collected over 24 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Bioequivalence based on AUC0-inf

Outcome measures

Measure	Ondansetron n=24 Participants Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in either period	Zofran® n=24 Participants Zofran® 8 mg ODT (reference) dosed in either period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)	293.492 ng*h/mL Standard Deviation 172.394	303.106 ng*h/mL Standard Deviation 172.148

PRIMARY outcome

Timeframe: Blood samples collected over 24 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Bioequivalence based on AUC0-t

Outcome measures

Measure	Ondansetron n=24 Participants Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in either period	Zofran® n=24 Participants Zofran® 8 mg ODT (reference) dosed in either period
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)	270.928 ng*h/mL Standard Deviation 151.776	276.641 ng*h/mL Standard Deviation 142.500

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Manager, Biopharmaceutics

Teva Pharmaceuticals USA

Phone: 1-866-384-5525

Email: clinicaltrialqueries@tevausa.com

Results disclosure agreements

• Principal investigator is a sponsor employee Principal Investigator is not permitted to discuss or publish trial results.
• Publication restrictions are in place

Restriction type: OTHER