Trial Outcomes & Findings for Granisetron 1 mg Tablets Under Fasting Conditions (NCT NCT00834717)

NCT ID: NCT00834717

Last Updated: 2024-08-19

Results Overview

Bioequivalence based on Cmax

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 40 participants
• Primary outcome timeframe: Blood samples collected over 72 hour period
• Results posted on: 2024-08-19

Participant Flow

Participant milestones

Measure	Granisetron (Test) First Granisetron 1 mg Tablet (test) dosed in first period followed by Kytril® 1 mg Tablet (reference) dosed in second period	Kytril® (Reference) First Kytril 1 mg Tablet (reference) dosed in first period followed by Granisetron 1 mg Tablet (test) dosed in second period
First Intervention STARTED	20	20
First Intervention COMPLETED	19	19
First Intervention NOT COMPLETED	1	1
Second Intervention STARTED	19	19
Second Intervention COMPLETED	19	19
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Granisetron (Test) First Granisetron 1 mg Tablet (test) dosed in first period followed by Kytril® 1 mg Tablet (reference) dosed in second period	Kytril® (Reference) First Kytril 1 mg Tablet (reference) dosed in first period followed by Granisetron 1 mg Tablet (test) dosed in second period
First Intervention Adverse Event	1	0
First Intervention Withdrawal by Subject	0	1

Baseline Characteristics

Granisetron 1 mg Tablets Under Fasting Conditions

Baseline characteristics by cohort

Measure	Granisetron (Test) First n=20 Participants Granisetron 1 mg Tablet (test) dosed in first period followed by Kytril® 1 mg Tablet (reference) dosed in second period	Kytril® (Reference) First n=20 Participants Kytril 1 mg Tablet (reference) dosed in first period followed by Granisetron 1 mg Tablet (test) dosed in second period	Total n=40 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	20 Participants n=5 Participants	20 Participants n=7 Participants	40 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	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	17 Participants n=5 Participants	15 Participants n=7 Participants	32 Participants n=5 Participants
Race/Ethnicity, Customized Black	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment Canada	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: Blood samples collected over 72 hour period

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

Bioequivalence based on Cmax

Outcome measures

Measure	Granisetron n=38 Participants Granisetron 1 mg Tablet (test) dosed in either period	Kytril® n=38 Participants Kytril 1 mg Tablet (reference) dosed in either period
Cmax (Maximum Observed Concentration)	10.7738 ng/mL Standard Deviation 3.1855	11.0935 ng/mL Standard Deviation 3.4983

PRIMARY outcome

Timeframe: Blood samples collected over 72 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	Granisetron n=38 Participants Granisetron 1 mg Tablet (test) dosed in either period	Kytril® n=38 Participants Kytril 1 mg Tablet (reference) dosed in either period
Auc0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)]	148.5875 ng*h/mL Standard Deviation 89.7077	160.5850 ng*h/mL Standard Deviation 99.0854

PRIMARY outcome

Timeframe: Bl;ood samples collected over 36 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	Granisetron n=38 Participants Granisetron 1 mg Tablet (test) dosed in either period	Kytril® n=38 Participants Kytril 1 mg Tablet (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)]	145.4357 ng*h/mL Standard Deviation 86.4059	156.0218 ng*h/mL Standard Deviation 93.5907

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