Trial Outcomes & Findings for Lansoprazole 30 mg DR Capsule Fasting Study (NCT NCT01045967)
NCT ID: NCT01045967
Last Updated: 2010-12-08
Results Overview
Bioequivalence based on Cmax.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
56 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 DR Capsules test product dosed in first period followed by 30 mg Prevacid® DR Capsules reference product dosed in the second period.
|
Reference (Prevacid®) First
30 mg Prevacid® DR Capsules reference product dosed in first period followed by 30 mg Lansoprazole DR Capsules test product dosed in the second period.
|
|---|---|---|
|
First Intervention
STARTED
|
28
|
28
|
|
First Intervention
COMPLETED
|
28
|
28
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout of 7 Days
STARTED
|
28
|
28
|
|
Washout of 7 Days
COMPLETED
|
28
|
28
|
|
Washout of 7 Days
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
28
|
28
|
|
Second Intervention
COMPLETED
|
28
|
27
|
|
Second Intervention
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Test (Lansoprazole) First
30 mg Lansoprazole DR Capsules test product dosed in first period followed by 30 mg Prevacid® DR Capsules reference product dosed in the second period.
|
Reference (Prevacid®) First
30 mg Prevacid® DR Capsules reference product dosed in first period followed by 30 mg Lansoprazole DR Capsules test product dosed in the second period.
|
|---|---|---|
|
Second Intervention
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Lansoprazole 30 mg DR Capsule Fasting Study
Baseline characteristics by cohort
| Measure |
Test (Lansoprazole) First
n=28 Participants
30 mg Lansoprazole DR Capsules test product dosed in first period followed by 30 mg Prevacid® DR Capsules reference product dosed in the second period.
|
Reference (Prevacid®) First
n=28 Participants
30 mg Prevacid® DR Capsules reference product dosed in first period followed by 30 mg Lansoprazole DR Capsules test product dosed in the second period.
|
Total
n=56 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
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
56 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
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
27 participants
n=5 Participants
|
27 participants
n=7 Participants
|
54 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
Hispanic
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
28 participants
n=7 Participants
|
56 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.
Bioequivalence based on Cmax.
Outcome measures
| Measure |
Test (Lansoprazole)
n=55 Participants
30 mg Lansoprazole DR Capsules test product dosed in either period.
|
Reference (Prevacid®)
n=55 Participants
30 mg Prevacid® DR Capsules reference product dosed in either period.
|
|---|---|---|
|
Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
|
939.025 ng/mL
Standard Deviation 438.28
|
865.678 ng/mL
Standard Deviation 359.365
|
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 (Lansoprazole)
n=55 Participants
30 mg Lansoprazole DR Capsules test product dosed in either period.
|
Reference (Prevacid®)
n=55 Participants
30 mg Prevacid® DR Capsules reference product dosed in either period.
|
|---|---|---|
|
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
|
2156.104 ng*h/mL
Standard Deviation 1746.337
|
2130.082 ng*h/mL
Standard Deviation 1486.442
|
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 (Lansoprazole)
n=55 Participants
30 mg Lansoprazole DR Capsules test product dosed in either period.
|
Reference (Prevacid®)
n=55 Participants
30 mg Prevacid® DR Capsules reference product dosed in either period.
|
|---|---|---|
|
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
|
2253.776 ng*h/mL
Standard Deviation 2126.251
|
2195.918 ng*h/mL
Standard Deviation 1667.722
|
Adverse Events
Test (Lansoprazole)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Reference (Prevacid®)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test (Lansoprazole)
n=56 participants at risk
30 mg Lansoprazole DR Capsules test product dosed in either period.
|
Reference (Prevacid®)
n=56 participants at risk
30 mg Prevacid® DR Capsules reference product dosed in either period.
|
|---|---|---|
|
General disorders
Dizziness
|
5.4%
3/56 • Number of events 3 • Adverse event data was collected over the course of the study, which was approximately 2 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.
|
0.00%
0/56 • Adverse event data was collected over the course of the study, which was approximately 2 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.
|
|
General disorders
Headache
|
5.4%
3/56 • Number of events 3 • Adverse event data was collected over the course of the study, which was approximately 2 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.
|
5.4%
3/56 • Number of events 3 • Adverse event data was collected over the course of the study, which was approximately 2 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