Trial Outcomes & Findings for Drug Interaction With Proton Pump Inhibitors for Nifedipine ER Tablets (NCT NCT03100838)
NCT ID: NCT03100838
Last Updated: 2019-08-16
Results Overview
Measurement of plasma nifedipine prior to dosing and at times 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 20, 24, 36 and 48 hr after nifedipine administration.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
64 participants
Primary outcome timeframe
48 hours
Results posted on
2019-08-16
Participant Flow
A total of 64 subjects were dosed.
Participant milestones
| Measure |
Sequence 1 (ABCD)
A Generic 1 x 60 mg Nifedipine extended-release tablet
B Brand (Procardia XL)
1 x 60 mg Nifedipine extended-release tablet
C Generic+PPI (antacids) 1 x 60 mg Nifedipine extended-release tablet 7 x 40 mg omeprazole/1100 mg sodium bicarbonate capsules
D Brand (Procardia XL) +PPI (antacids)
1 x 60 mg Nifedipine extended-release tablet 7 x 40 mg omeprazole/1100 mg sodium bicarbonate capsules
A washout period of at least 14 days occurs between each intervention.
SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology
|
Sequence 2 (BCDA)
A Generic 1 x 60 mg Nifedipine extended-release tablet
B Brand (Procardia XL)
1 x 60 mg Nifedipine extended-release tablet
C Generic+PPI (antacids) 1 x 60 mg Nifedipine extended-release tablet 7 x 40 mg omeprazole/1100 mg sodium bicarbonate capsules
D Brand (Procardia XL) +PPI (antacids)
1 x 60 mg Nifedipine extended-release tablet 7 x 40 mg omeprazole/1100 mg sodium bicarbonate capsules
A washout period of at least 14 days occurs between each intervention.
SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology
|
Sequence 3 (CDAB)
A Generic 1 x 60 mg Nifedipine extended-release tablet
B Brand (Procardia)
1 x 60 mg Nifedipine extended-release tablet
C Generic+PPI (antacids) 1 x 60 mg Nifedipine extended-release tablet 7 x 40 mg omeprazole/1100 mg sodium bicarbonate capsules
D Brand (Procardia) +PPI (antacids)
1 x 60 mg Nifedipine extended-release tablet 7 x 40 mg omeprazole/1100 mg sodium bicarbonate capsules
A washout period of at least 14 days occurs between each intervention.
SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology
|
Sequence 4 (DABC)
A Generic 1 x 60 mg Nifedipine extended-release tablet
B Brand (Procardia XL)
1 x 60 mg Nifedipine extended-release tablet
C Generic+PPI (antacids) 1 x 60 mg Nifedipine extended-release tablet 7 x 40 mg omeprazole/1100 mg sodium bicarbonate capsules
D Brand (Procardia XL) +PPI (antacids)
1 x 60 mg Nifedipine extended-release tablet 7 x 40 mg omeprazole/1100 mg sodium bicarbonate capsules
A washout period of at least 14 days occurs between each intervention.
SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
16
|
16
|
|
Overall Study
COMPLETED
|
14
|
14
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
2
|
1
|
Reasons for withdrawal
| Measure |
Sequence 1 (ABCD)
A Generic 1 x 60 mg Nifedipine extended-release tablet
B Brand (Procardia XL)
1 x 60 mg Nifedipine extended-release tablet
C Generic+PPI (antacids) 1 x 60 mg Nifedipine extended-release tablet 7 x 40 mg omeprazole/1100 mg sodium bicarbonate capsules
D Brand (Procardia XL) +PPI (antacids)
1 x 60 mg Nifedipine extended-release tablet 7 x 40 mg omeprazole/1100 mg sodium bicarbonate capsules
A washout period of at least 14 days occurs between each intervention.
SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology
|
Sequence 2 (BCDA)
A Generic 1 x 60 mg Nifedipine extended-release tablet
B Brand (Procardia XL)
1 x 60 mg Nifedipine extended-release tablet
C Generic+PPI (antacids) 1 x 60 mg Nifedipine extended-release tablet 7 x 40 mg omeprazole/1100 mg sodium bicarbonate capsules
D Brand (Procardia XL) +PPI (antacids)
1 x 60 mg Nifedipine extended-release tablet 7 x 40 mg omeprazole/1100 mg sodium bicarbonate capsules
A washout period of at least 14 days occurs between each intervention.
SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology
|
Sequence 3 (CDAB)
A Generic 1 x 60 mg Nifedipine extended-release tablet
B Brand (Procardia)
1 x 60 mg Nifedipine extended-release tablet
C Generic+PPI (antacids) 1 x 60 mg Nifedipine extended-release tablet 7 x 40 mg omeprazole/1100 mg sodium bicarbonate capsules
D Brand (Procardia) +PPI (antacids)
1 x 60 mg Nifedipine extended-release tablet 7 x 40 mg omeprazole/1100 mg sodium bicarbonate capsules
A washout period of at least 14 days occurs between each intervention.
SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology
|
Sequence 4 (DABC)
A Generic 1 x 60 mg Nifedipine extended-release tablet
B Brand (Procardia XL)
1 x 60 mg Nifedipine extended-release tablet
C Generic+PPI (antacids) 1 x 60 mg Nifedipine extended-release tablet 7 x 40 mg omeprazole/1100 mg sodium bicarbonate capsules
D Brand (Procardia XL) +PPI (antacids)
1 x 60 mg Nifedipine extended-release tablet 7 x 40 mg omeprazole/1100 mg sodium bicarbonate capsules
A washout period of at least 14 days occurs between each intervention.
SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
1
|
1
|
1
|
1
|
|
Overall Study
Pregnancy
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Drug Interaction With Proton Pump Inhibitors for Nifedipine ER Tablets
Baseline characteristics by cohort
| Measure |
All Participants
n=59 Participants
Participants were randomized to one of the four sequences and were to receive all interventions.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
59 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 hoursMeasurement of plasma nifedipine prior to dosing and at times 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 20, 24, 36 and 48 hr after nifedipine administration.
Outcome measures
| Measure |
Nifedipine (Generic)
n=59 Participants
1 x 60 mg Nifedipine extended-release tablet
NIFEdipine 60 MG: Test Drug
SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology
|
Nifedipine (Brand)
n=59 Participants
1 x 60 mg PROCARDIA XL (nifedipine) extended-release tablet
NIFEdipine 60 MG: Reference Drug
SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology
|
Nifedipine (Generic) + PPI
n=57 Participants
1 x 40 mg/1100 mg omeprazole/sodium bicarbonate capsule daily over a period of 7 days + 1 x 60 mg Nifedipine extended-release tablet on day 7
NIFEdipine 60 MG: Test Drug
omeprazole/sodium bicarbonate: Proton Pump Inhibitor/Antacid for drug-drug interaction
|
Nifedipine (Brand) + PPI
n=55 Participants
1 x 40 mg/1100 mg omeprazole/sodium bicarbonate capsule daily over a period of 7 days + 1 x 60 mg PROCARDIA XL (nifedipine) extended-release tablet on day 7
NIFEdipine 60 MG: Reference Drug
omeprazole/sodium bicarbonate: Proton Pump Inhibitor/Antacid for drug-drug interaction
|
|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
94.37 ng/mL
Standard Deviation 42.42
|
43.84 ng/mL
Standard Deviation 44.07
|
106.35 ng/mL
Standard Deviation 43.67
|
51.65 ng/mL
Standard Deviation 32.47
|
PRIMARY outcome
Timeframe: 48 hoursMeasurement of plasma nifedipine prior to dosing and at times 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 20, 24, 36 and 48 hr after nifedipine administration.
Outcome measures
| Measure |
Nifedipine (Generic)
n=59 Participants
1 x 60 mg Nifedipine extended-release tablet
NIFEdipine 60 MG: Test Drug
SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology
|
Nifedipine (Brand)
n=59 Participants
1 x 60 mg PROCARDIA XL (nifedipine) extended-release tablet
NIFEdipine 60 MG: Reference Drug
SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology
|
Nifedipine (Generic) + PPI
n=59 Participants
1 x 40 mg/1100 mg omeprazole/sodium bicarbonate capsule daily over a period of 7 days + 1 x 60 mg Nifedipine extended-release tablet on day 7
NIFEdipine 60 MG: Test Drug
omeprazole/sodium bicarbonate: Proton Pump Inhibitor/Antacid for drug-drug interaction
|
Nifedipine (Brand) + PPI
n=59 Participants
1 x 40 mg/1100 mg omeprazole/sodium bicarbonate capsule daily over a period of 7 days + 1 x 60 mg PROCARDIA XL (nifedipine) extended-release tablet on day 7
NIFEdipine 60 MG: Reference Drug
omeprazole/sodium bicarbonate: Proton Pump Inhibitor/Antacid for drug-drug interaction
|
|---|---|---|---|---|
|
Time at Maximum Plasma Concentration (Tmax)
|
4 hr
Interval 2.0 to 16.0
|
16 hr
Interval 3.0 to 36.0
|
6 hr
Interval 3.0 to 24.0
|
16 hr
Interval 5.0 to 36.02
|
PRIMARY outcome
Timeframe: 48 hoursTime curve from time zero to last measurable concentration. Measurement of plasma nifedipine prior to dosing and at times 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 20, 24, 36 and 48 hr after nifedipine administration.
Outcome measures
| Measure |
Nifedipine (Generic)
n=59 Participants
1 x 60 mg Nifedipine extended-release tablet
NIFEdipine 60 MG: Test Drug
SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology
|
Nifedipine (Brand)
n=59 Participants
1 x 60 mg PROCARDIA XL (nifedipine) extended-release tablet
NIFEdipine 60 MG: Reference Drug
SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology
|
Nifedipine (Generic) + PPI
n=59 Participants
1 x 40 mg/1100 mg omeprazole/sodium bicarbonate capsule daily over a period of 7 days + 1 x 60 mg Nifedipine extended-release tablet on day 7
NIFEdipine 60 MG: Test Drug
omeprazole/sodium bicarbonate: Proton Pump Inhibitor/Antacid for drug-drug interaction
|
Nifedipine (Brand) + PPI
n=59 Participants
1 x 40 mg/1100 mg omeprazole/sodium bicarbonate capsule daily over a period of 7 days + 1 x 60 mg PROCARDIA XL (nifedipine) extended-release tablet on day 7
NIFEdipine 60 MG: Reference Drug
omeprazole/sodium bicarbonate: Proton Pump Inhibitor/Antacid for drug-drug interaction
|
|---|---|---|---|---|
|
Area Under the Concentration (AUC 0-t)
|
1166.21 ng.h/mL
Standard Deviation 45.64
|
1061.49 ng.h/mL
Standard Deviation 47.52
|
1514.83 ng.h/mL
Standard Deviation 29.95
|
1239.26 ng.h/mL
Standard Deviation 40.68
|
PRIMARY outcome
Timeframe: 48 hoursThe apparent terminal exponential half-life. Measurement of plasma nifedipine prior to dosing and at times 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 20, 24, 36 and 48 hr after nifedipine administration.
Outcome measures
| Measure |
Nifedipine (Generic)
n=59 Participants
1 x 60 mg Nifedipine extended-release tablet
NIFEdipine 60 MG: Test Drug
SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology
|
Nifedipine (Brand)
n=59 Participants
1 x 60 mg PROCARDIA XL (nifedipine) extended-release tablet
NIFEdipine 60 MG: Reference Drug
SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology
|
Nifedipine (Generic) + PPI
n=59 Participants
1 x 40 mg/1100 mg omeprazole/sodium bicarbonate capsule daily over a period of 7 days + 1 x 60 mg Nifedipine extended-release tablet on day 7
NIFEdipine 60 MG: Test Drug
omeprazole/sodium bicarbonate: Proton Pump Inhibitor/Antacid for drug-drug interaction
|
Nifedipine (Brand) + PPI
n=59 Participants
1 x 40 mg/1100 mg omeprazole/sodium bicarbonate capsule daily over a period of 7 days + 1 x 60 mg PROCARDIA XL (nifedipine) extended-release tablet on day 7
NIFEdipine 60 MG: Reference Drug
omeprazole/sodium bicarbonate: Proton Pump Inhibitor/Antacid for drug-drug interaction
|
|---|---|---|---|---|
|
Half-life
|
8.59 hr
Standard Deviation 33.15
|
11.29 hr
Standard Deviation 82.39
|
8.10 hr
Standard Deviation 32.64
|
12.71 hr
Standard Deviation 119.78
|
SECONDARY outcome
Timeframe: 66 daysReported from the start of the first session to the follow-up visit.
Outcome measures
| Measure |
Nifedipine (Generic)
n=59 Participants
1 x 60 mg Nifedipine extended-release tablet
NIFEdipine 60 MG: Test Drug
SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology
|
Nifedipine (Brand)
n=59 Participants
1 x 60 mg PROCARDIA XL (nifedipine) extended-release tablet
NIFEdipine 60 MG: Reference Drug
SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology
|
Nifedipine (Generic) + PPI
n=59 Participants
1 x 40 mg/1100 mg omeprazole/sodium bicarbonate capsule daily over a period of 7 days + 1 x 60 mg Nifedipine extended-release tablet on day 7
NIFEdipine 60 MG: Test Drug
omeprazole/sodium bicarbonate: Proton Pump Inhibitor/Antacid for drug-drug interaction
|
Nifedipine (Brand) + PPI
n=59 Participants
1 x 40 mg/1100 mg omeprazole/sodium bicarbonate capsule daily over a period of 7 days + 1 x 60 mg PROCARDIA XL (nifedipine) extended-release tablet on day 7
NIFEdipine 60 MG: Reference Drug
omeprazole/sodium bicarbonate: Proton Pump Inhibitor/Antacid for drug-drug interaction
|
|---|---|---|---|---|
|
Adverse Events
|
37 Events
|
19 Events
|
51 Events
|
38 Events
|
Adverse Events
Nifedipine (Generic)
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Nifedipine (Brand)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Nifedipine (Generic) + PPI
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
Nifedipine (Brand) + PPI
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nifedipine (Generic)
n=59 participants at risk
1 x 60 mg Nifedipine extended-release tablet
NIFEdipine 60 MG: Test Drug
SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology
|
Nifedipine (Brand)
n=59 participants at risk
1 x 60 mg PROCARDIA XL (nifedipine) extended-release tablet
NIFEdipine 60 MG: Reference Drug
SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology
|
Nifedipine (Generic) + PPI
n=59 participants at risk
1 x 40 mg/1100 mg omeprazole/sodium bicarbonate capsule daily over a period of 8 days + 60 mg Nifedipine extended-release tablet on day 7
NIFEdipine 60 MG: Test Drug
omeprazole/sodium bicarbonate: Proton Pump Inhibitor/Antacid for drug-drug interaction
SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology
|
Nifedipine (Brand) + PPI
n=59 participants at risk
1 x 40 mg/1100 mg omeprazole/sodium bicarbonate capsule daily over a period of 8 days + 60 mg PROCARDIA XL (nifedipine) extended-release tablet on day 7
NIFEdipine 60 MG: Reference Drug
omeprazole/sodium bicarbonate: Proton Pump Inhibitor/Antacid for drug-drug interaction
SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
33.9%
20/59 • Approximately 2 months
|
23.7%
14/59 • Approximately 2 months
|
42.4%
25/59 • Approximately 2 months
|
37.3%
22/59 • Approximately 2 months
|
|
Gastrointestinal disorders
Constipation
|
1.7%
1/59 • Approximately 2 months
|
1.7%
1/59 • Approximately 2 months
|
8.5%
5/59 • Approximately 2 months
|
3.4%
2/59 • Approximately 2 months
|
|
Gastrointestinal disorders
Nausea
|
1.7%
1/59 • Approximately 2 months
|
0.00%
0/59 • Approximately 2 months
|
8.5%
5/59 • Approximately 2 months
|
3.4%
2/59 • Approximately 2 months
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/59 • Approximately 2 months
|
0.00%
0/59 • Approximately 2 months
|
5.1%
3/59 • Approximately 2 months
|
3.4%
2/59 • Approximately 2 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60