Trial Outcomes & Findings for Lansoprazole 30 mg DR Capsule Fasting Replicate Sprinkle Study (NCT NCT01046253)
NCT ID: NCT01046253
Last Updated: 2010-12-08
Results Overview
Bioequivalence based on Cmax.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
50 participants
Primary outcome timeframe
Blood samples collected over a 12 hour period.
Results posted on
2010-12-08
Participant Flow
Participant milestones
| Measure |
Test (Lansoprazole) First
30 mg Lansoprazole Delayed-Release Capsules test product dosed in first and third periods followed by 30 mg Prevacid® Capsules reference product dosed in the second and fourth periods.
|
Reference (Prevacid®) First
30 mg Prevacid® Capsules reference product dosed in first and third period followed by 30 mg Lansoprazole Delayed-Release Capsules test product dosed in the second and fourth period.
|
|---|---|---|
|
First Intervention
STARTED
|
25
|
25
|
|
First Intervention
COMPLETED
|
25
|
25
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
First Washout of 7 Days
STARTED
|
25
|
25
|
|
First Washout of 7 Days
COMPLETED
|
25
|
25
|
|
First Washout of 7 Days
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
25
|
25
|
|
Second Intervention
COMPLETED
|
25
|
23
|
|
Second Intervention
NOT COMPLETED
|
0
|
2
|
|
Second Washout of 7 Days
STARTED
|
25
|
23
|
|
Second Washout of 7 Days
COMPLETED
|
25
|
23
|
|
Second Washout of 7 Days
NOT COMPLETED
|
0
|
0
|
|
Third Intervention
STARTED
|
25
|
23
|
|
Third Intervention
COMPLETED
|
25
|
23
|
|
Third Intervention
NOT COMPLETED
|
0
|
0
|
|
Third Washout of 7 Days
STARTED
|
25
|
23
|
|
Third Washout of 7 Days
COMPLETED
|
25
|
23
|
|
Third Washout of 7 Days
NOT COMPLETED
|
0
|
0
|
|
Fourth Intervention
STARTED
|
25
|
23
|
|
Fourth Intervention
COMPLETED
|
25
|
23
|
|
Fourth Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Test (Lansoprazole) First
30 mg Lansoprazole Delayed-Release Capsules test product dosed in first and third periods followed by 30 mg Prevacid® Capsules reference product dosed in the second and fourth periods.
|
Reference (Prevacid®) First
30 mg Prevacid® Capsules reference product dosed in first and third period followed by 30 mg Lansoprazole Delayed-Release Capsules test product dosed in the second and fourth period.
|
|---|---|---|
|
Second Intervention
Adverse Event
|
0
|
1
|
|
Second Intervention
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Lansoprazole 30 mg DR Capsule Fasting Replicate Sprinkle Study
Baseline characteristics by cohort
| Measure |
Test (Lansoprazole) First
n=25 Participants
30 mg Lansoprazole Delayed-Release Capsules test product dosed in first and third periods followed by 30 mg Prevacid® Capsules reference product dosed in the second and fourth periods.
|
Reference (Prevacid®) First
n=25 Participants
30 mg Prevacid® Capsules reference product dosed in first and third period followed by 30 mg Lansoprazole Delayed-Release Capsules test product dosed in the second and fourth period.
|
Total
n=50 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
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 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
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
24 participants
n=5 Participants
|
20 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over a 12 hour period.Population: All participants that completed the study had their samples analyzed. Replicate study design allowed for 2 sets of samples per subject per treatment (N=96 for both test and reference).
Bioequivalence based on Cmax.
Outcome measures
| Measure |
Test (Lansoprazole)
n=96 Participants
30 mg Lansoprazole Delayed-Release Capsules test product dosed in any period.
|
Reference (Prevacid®)
n=96 Participants
30 mg Prevacid® Capsules reference product dosed in any period.
|
|---|---|---|
|
Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
|
782.438 ng/mL
Standard Deviation 304.196
|
738.531 ng/mL
Standard Deviation 294.692
|
PRIMARY outcome
Timeframe: Blood samples collected over a 12 hour period.Population: All participants that completed the study had their samples analyzed. Replicate study design allowed for 2 sets of samples per subject per treatment (N=96 for both test and reference).
Bioequivalence based on AUC0-t.
Outcome measures
| Measure |
Test (Lansoprazole)
n=96 Participants
30 mg Lansoprazole Delayed-Release Capsules test product dosed in any period.
|
Reference (Prevacid®)
n=96 Participants
30 mg Prevacid® Capsules reference product dosed in any period.
|
|---|---|---|
|
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
|
1938.669 ng*h/mL
Standard Deviation 1187.39
|
1982.598 ng*h/mL
Standard Deviation 1300.059
|
PRIMARY outcome
Timeframe: Blood samples collected over a 12 hour period.Population: All participants that completed the study had their samples analyzed. Replicate study design allowed for 2 sets of samples per subject per treatment (N=96 for both test and reference).
Bioequivalence based on AUC0-inf.
Outcome measures
| Measure |
Test (Lansoprazole)
n=96 Participants
30 mg Lansoprazole Delayed-Release Capsules test product dosed in any period.
|
Reference (Prevacid®)
n=96 Participants
30 mg Prevacid® Capsules reference product dosed in any period.
|
|---|---|---|
|
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
|
1998.063 ng*h/mL
Standard Deviation 1310.811
|
2052.519 ng*h/mL
Standard Deviation 1467.575
|
Adverse Events
Test (Lansoprazole) First
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Reference (Prevacid®) First
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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