Trial Outcomes & Findings for Granisetron 1 mg Tablets, Non-fasting (NCT NCT00834522)
NCT ID: NCT00834522
Last Updated: 2024-08-19
Results Overview
Bioequivalence based on Cmax
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
80 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 2 x 1 mg Tablet (test) dosed in first period followed by Kytril® 2 x 1 mg Tablet (reference) dosed in second period
|
Kytril® (Reference) First
Kytril® 2 x 1 mg Tablet (reference) dosed in first period followed by Granisetron 2 x 1 mg Tablet (test) dosed in second period
|
|---|---|---|
|
First Intervention
STARTED
|
40
|
40
|
|
First Intervention
COMPLETED
|
40
|
40
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout
STARTED
|
40
|
40
|
|
Washout
COMPLETED
|
37
|
39
|
|
Washout
NOT COMPLETED
|
3
|
1
|
|
Second Intervention
STARTED
|
37
|
39
|
|
Second Intervention
COMPLETED
|
37
|
39
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Granisetron (Test) First
Granisetron 2 x 1 mg Tablet (test) dosed in first period followed by Kytril® 2 x 1 mg Tablet (reference) dosed in second period
|
Kytril® (Reference) First
Kytril® 2 x 1 mg Tablet (reference) dosed in first period followed by Granisetron 2 x 1 mg Tablet (test) dosed in second period
|
|---|---|---|
|
Washout
Adverse Event
|
1
|
0
|
|
Washout
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Granisetron 1 mg Tablets, Non-fasting
Baseline characteristics by cohort
| Measure |
Granisetron (Test) First
n=40 Participants
Granisetron 2 x 1 mg Tablet (test) dosed in first period followed by Kytril® 2 x 1 mg Tablet (reference) dosed in second period
|
Kytril® (Reference) First
n=40 Participants
Kytril® 2 x 1 mg Tablet (reference) dosed in first period followed by Granisetron 2 x 1 mg Tablet (test) dosed in second period
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
34 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
40 participants
n=99 Participants
|
40 participants
n=107 Participants
|
80 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over 72 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on Cmax
Outcome measures
| Measure |
Granisetron
n=76 Participants
Granisetron 2 x 1 mg Tablet (test) dosed in either period
|
Kytril®
n=76 Participants
Kytril® 2 x 1 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
Cmax (Maximum Observed Concentration)
|
10.4016 ng/mL
Standard Deviation 3.4598
|
10.1061 ng/mL
Standard Deviation 3.2848
|
PRIMARY outcome
Timeframe: Blood samples collected over 72 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on AUC0-inf
Outcome measures
| Measure |
Granisetron
n=76 Participants
Granisetron 2 x 1 mg Tablet (test) dosed in either period
|
Kytril®
n=76 Participants
Kytril® 2 x 1 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)]
|
130.3581 ng*h/mL
Standard Deviation 68.2310
|
126.9140 ng*h/mL
Standard Deviation 72.9558
|
PRIMARY outcome
Timeframe: Blood samples collected over 72 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on AUC0-t
Outcome measures
| Measure |
Granisetron
n=76 Participants
Granisetron 2 x 1 mg Tablet (test) dosed in either period
|
Kytril®
n=76 Participants
Kytril® 2 x 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)]
|
127.6581 ng*h/mL
Standard Deviation 66.0753
|
124.4104 ng*h/mL
Standard Deviation 70.2712
|
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
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