Trial Outcomes & Findings for Sumatriptan Succinate 100 mg Tablets Under Non-Fasting Conditions (NCT NCT00846885)
NCT ID: NCT00846885
Last Updated: 2009-09-11
Results Overview
Bioequivalence based on Cmax.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
Blood samples collected over a 12 hour period.
Results posted on
2009-09-11
Participant Flow
Participant milestones
| Measure |
Test (Sumatriptan) First
100 mg Sumatriptan Tablets test product dosed in first period followed by 100 mg Imitrex® Tablets reference product dosed in the second period.
|
Reference (Imitrex®) First
100 mg Imitrex® Tablets reference product dosed in first period followed by 100 mg Sumatriptan Tablets test product dosed in the second period.
|
|---|---|---|
|
First Intervention
STARTED
|
14
|
14
|
|
First Intervention
COMPLETED
|
14
|
14
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout of 7 Days
STARTED
|
14
|
14
|
|
Washout of 7 Days
COMPLETED
|
14
|
14
|
|
Washout of 7 Days
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
14
|
14
|
|
Second Intervention
COMPLETED
|
14
|
14
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sumatriptan Succinate 100 mg Tablets Under Non-Fasting Conditions
Baseline characteristics by cohort
| Measure |
Test (Sumatriptan) First
n=14 Participants
100 mg Sumatriptan Tablets test product dosed in first period followed by 100 mg Imitrex® Tablets reference product dosed in the second period.
|
Reference (Imitrex®) First
n=14 Participants
100 mg Imitrex® Tablets reference product dosed in first period followed by 100 mg Sumatriptan Tablets test product dosed in the second period.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 participants
n=93 Participants
|
7 participants
n=4 Participants
|
10 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
11 participants
n=93 Participants
|
6 participants
n=4 Participants
|
17 participants
n=27 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=93 Participants
|
14 participants
n=4 Participants
|
28 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over a 12 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Cmax.
Outcome measures
| Measure |
Test (Sumatriptan)
n=28 Participants
100 mg Sumatriptan Tablets test product dosed in either period.
|
Reference (Imitrex®)
n=28 Participants
100 mg Imitrex® Tablets reference product dosed in either period.
|
|---|---|---|
|
Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
|
80.334 ng/mL
Standard Deviation 43.6
|
71.483 ng/mL
Standard Deviation 32.193
|
PRIMARY outcome
Timeframe: Blood samples collected over a 12 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on AUC0-t.
Outcome measures
| Measure |
Test (Sumatriptan)
n=28 Participants
100 mg Sumatriptan Tablets test product dosed in either period.
|
Reference (Imitrex®)
n=28 Participants
100 mg Imitrex® Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
|
305.374 ng*h/mL
Standard Deviation 116.446
|
288.099 ng*h/mL
Standard Deviation 109.217
|
PRIMARY outcome
Timeframe: Blood samples collected over a 12 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on AUC0-inf.
Outcome measures
| Measure |
Test (Sumatriptan)
n=28 Participants
100 mg Sumatriptan Tablets test product dosed in either period.
|
Reference (Imitrex®)
n=28 Participants
100 mg Imitrex® Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
|
314.996 ng*h/mL
Standard Deviation 117.628
|
298.953 ng*h/mL
Standard Deviation 111.361
|
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