Trial Outcomes & Findings for Lansoprazole 30 mg DR Capsule Replicate Food Study (NCT NCT01046084)
NCT ID: NCT01046084
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 14 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 500 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 periods followed by 30 mg Lansoprazole Capsules test product dosed in the second and fourth periods.
|
|---|---|---|
|
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
|
25
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
|
Second Washout of 7 Days
STARTED
|
25
|
25
|
|
Second Washout of 7 Days
COMPLETED
|
25
|
25
|
|
Second Washout of 7 Days
NOT COMPLETED
|
0
|
0
|
|
Third Intervention
STARTED
|
25
|
25
|
|
Third Intervention
COMPLETED
|
25
|
25
|
|
Third Intervention
NOT COMPLETED
|
0
|
0
|
|
Third Washout of 7 Days
STARTED
|
25
|
25
|
|
Third Washout of 7 Days
COMPLETED
|
23
|
25
|
|
Third Washout of 7 Days
NOT COMPLETED
|
2
|
0
|
|
Fourth Intervention
STARTED
|
23
|
25
|
|
Fourth Intervention
COMPLETED
|
23
|
25
|
|
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 500 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 periods followed by 30 mg Lansoprazole Capsules test product dosed in the second and fourth periods.
|
|---|---|---|
|
Third Washout of 7 Days
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Lansoprazole 30 mg DR Capsule Replicate Food 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 500 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 periods followed by 30 mg Lansoprazole Capsules test product dosed in the second and fourth periods.
|
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
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
17 participants
n=5 Participants
|
19 participants
n=7 Participants
|
36 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 14 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)
|
272.038 ng/mL
Standard Deviation 231.03
|
238.043 ng/mL
Standard Deviation 175.201
|
PRIMARY outcome
Timeframe: Blood samples collected over a 14 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)
|
979.389 ng*h/mL
Standard Deviation 972.74
|
890.06 ng*h/mL
Standard Deviation 780.912
|
PRIMARY outcome
Timeframe: Blood samples collected over a 14 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)
|
1060.923 ng*h/mL
Standard Deviation 1066.033
|
938.857 ng*h/mL
Standard Deviation 839.984
|
Adverse Events
Test (Lansoprazole)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Reference (Prevacid®)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test (Lansoprazole)
n=50 participants at risk
30 mg Lansoprazole Delayed-Release Capsules test product dosed in any period.
|
Reference (Prevacid®)
n=50 participants at risk
30 mg Prevacid® Capsules reference product dosed in any period.
|
|---|---|---|
|
General disorders
Headache
|
10.0%
5/50 • Number of events 8 • Adverse event data was collected over the course of the study, which was approximately 4 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
10.0%
5/50 • Number of events 5 • Adverse event data was collected over the course of the study, which was approximately 4 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
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