Trial Outcomes & Findings for The Relative Bioavailability Study of Two Ropinirole 0.25 mg Tablets Under Fed Conditions (NCT NCT00830219)
NCT ID: NCT00830219
Last Updated: 2009-09-15
Results Overview
Bioequivalence based on Cmax.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
46 participants
Primary outcome timeframe
Blood samples collected over a 24 hour period.
Results posted on
2009-09-15
Participant Flow
Participant milestones
| Measure |
Test (Ropinirole HCl) First
0.25 mg Ropinirole HCl Tablets test product dosed in first period followed by 0.25 mg Requip® Tablets reference product dosed in the second period.
|
Reference (Requip®) First
0.25 mg Requip® Tablets reference product dosed in first period followed by 0.25 mg Ropinirole HCl Tablets test product dosed in the second period.
|
|---|---|---|
|
First Intervention
STARTED
|
23
|
23
|
|
First Intervention
COMPLETED
|
23
|
23
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout of 7 Days
STARTED
|
23
|
23
|
|
Washout of 7 Days
COMPLETED
|
22
|
22
|
|
Washout of 7 Days
NOT COMPLETED
|
1
|
1
|
|
Second Intervention
STARTED
|
22
|
22
|
|
Second Intervention
COMPLETED
|
22
|
22
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Test (Ropinirole HCl) First
0.25 mg Ropinirole HCl Tablets test product dosed in first period followed by 0.25 mg Requip® Tablets reference product dosed in the second period.
|
Reference (Requip®) First
0.25 mg Requip® Tablets reference product dosed in first period followed by 0.25 mg Ropinirole HCl Tablets test product dosed in the second period.
|
|---|---|---|
|
Washout of 7 Days
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
The Relative Bioavailability Study of Two Ropinirole 0.25 mg Tablets Under Fed Conditions
Baseline characteristics by cohort
| Measure |
Test (Ropinirole HCl) First
n=23 Participants
0.25 mg Ropinirole HCl Tablets test product dosed in first period followed by 0.25 mg Requip® Tablets reference product dosed in the second period.
|
Reference (Requip®) First
n=23 Participants
0.25 mg Requip® Tablets reference product dosed in first period followed by 0.25 mg Ropinirole HCl Tablets test product dosed in the second period.
|
Total
n=46 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
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 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
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
13 participants
n=5 Participants
|
16 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
23 participants
n=7 Participants
|
46 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over a 24 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Cmax.
Outcome measures
| Measure |
Test (Ropinirole HCl)
n=44 Participants
0.25 mg Ropinirole HCl Tablets test product dosed in either period.
|
Reference (Requip®)
n=44 Participants
0.25 mg Requip® Tablets reference product dosed in either period.
|
|---|---|---|
|
Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
|
564.09 pg/mL
Standard Deviation 174.53
|
543.71 pg/mL
Standard Deviation 168.9
|
PRIMARY outcome
Timeframe: Blood samples collected over a 24 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on AUC0-t.
Outcome measures
| Measure |
Test (Ropinirole HCl)
n=44 Participants
0.25 mg Ropinirole HCl Tablets test product dosed in either period.
|
Reference (Requip®)
n=44 Participants
0.25 mg Requip® Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
|
4300.07 pg*h/mL
Standard Deviation 1960.43
|
4209.47 pg*h/mL
Standard Deviation 1929.76
|
PRIMARY outcome
Timeframe: Blood samples collected over a 24 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on AUC0-inf.
Outcome measures
| Measure |
Test (Ropinirole HCl)
n=44 Participants
0.25 mg Ropinirole HCl Tablets test product dosed in either period.
|
Reference (Requip®)
n=44 Participants
0.25 mg Requip® Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
|
4551.89 pg*h/mL
Standard Deviation 2198.95
|
4441.31 pg*h/mL
Standard Deviation 2139.77
|
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 The Principal Investigator is not permitted to discuss or publish trial results.
- Publication restrictions are in place
Restriction type: OTHER