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Trial record 20 of 143 for:    NIFEDIPINE

Drug Interaction With Proton Pump Inhibitors for Nifedipine ER Tablets

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ClinicalTrials.gov Identifier: NCT03100838
Recruitment Status : Completed
First Posted : April 4, 2017
Results First Posted : July 22, 2019
Last Update Posted : August 16, 2019
Sponsor:
Collaborator:
BioPharma Services, Inc
Information provided by (Responsible Party):
Food and Drug Administration (FDA)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Healthy Volunteers
Interventions Drug: Nifedipine 60 MG Extended Release Oral Tablet
Drug: omeprazole/sodium bicarbonate
Device: SmartPill (TM)
Enrollment 64
Recruitment Details A total of 64 subjects were dosed.
Pre-assignment Details  
Arm/Group Title Sequence 1 (ABCD) Sequence 2 (BCDA) Sequence 3 (CDAB) Sequence 4 (DABC)
Hide Arm/Group Description

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

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

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

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

Period Title: Overall Study
Started 16 16 16 16
Completed 14 14 14 15
Not Completed 2 2 2 1
Reason Not Completed
Adverse Event             1             0             0             0
Physician Decision             1             1             1             1
Pregnancy             0             1             0             0
Lost to Follow-up             0             0             1             0
Arm/Group Title All Participants
Hide Arm/Group Description Participants were randomized to one of the four sequences and were to receive all interventions.
Overall Number of Baseline Participants 59
Hide Baseline Analysis Population Description
This is a crossover study. There are 64 subjects enrolled, but only 59 completed at least two treatments.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants
<=18 years
0
   0.0%
Between 18 and 65 years
59
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants
Female
40
  67.8%
Male
19
  32.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   1.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
32
  54.2%
White
21
  35.6%
More than one race
0
   0.0%
Unknown or Not Reported
5
   8.5%
1.Primary Outcome
Title Maximum Plasma Concentration (Cmax)
Hide Description 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.
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nifedipine (Generic) Nifedipine (Brand) Nifedipine (Generic) + PPI Nifedipine (Brand) + PPI
Hide Arm/Group Description:

1 x 60 mg Nifedipine extended-release tablet

NIFEdipine 60 MG: Test Drug

SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology

1 x 60 mg PROCARDIA XL (nifedipine) extended-release tablet

NIFEdipine 60 MG: Reference Drug

SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology

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

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

Overall Number of Participants Analyzed 59 59 57 55
Mean (Standard Deviation)
Unit of Measure: ng/mL
94.37  (42.42) 43.84  (44.07) 106.35  (43.67) 51.65  (32.47)
2.Primary Outcome
Title Time at Maximum Plasma Concentration (Tmax)
Hide Description 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.
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nifedipine (Generic) Nifedipine (Brand) Nifedipine (Generic) + PPI Nifedipine (Brand) + PPI
Hide Arm/Group Description:

1 x 60 mg Nifedipine extended-release tablet

NIFEdipine 60 MG: Test Drug

SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology

1 x 60 mg PROCARDIA XL (nifedipine) extended-release tablet

NIFEdipine 60 MG: Reference Drug

SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology

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

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

Overall Number of Participants Analyzed 59 59 59 59
Mean (Full Range)
Unit of Measure: hr
4
(2 to 16)
16
(3 to 36)
6
(3 to 24)
16
(5 to 36.02)
3.Primary Outcome
Title Area Under the Concentration (AUC 0-t)
Hide Description Time 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.
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nifedipine (Generic) Nifedipine (Brand) Nifedipine (Generic) + PPI Nifedipine (Brand) + PPI
Hide Arm/Group Description:

1 x 60 mg Nifedipine extended-release tablet

NIFEdipine 60 MG: Test Drug

SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology

1 x 60 mg PROCARDIA XL (nifedipine) extended-release tablet

NIFEdipine 60 MG: Reference Drug

SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology

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

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

Overall Number of Participants Analyzed 59 59 59 59
Mean (Standard Deviation)
Unit of Measure: ng.h/mL
1166.21  (45.64) 1061.49  (47.52) 1514.83  (29.95) 1239.26  (40.68)
4.Primary Outcome
Title Half-life
Hide Description The 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.
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nifedipine (Generic) Nifedipine (Brand) Nifedipine (Generic) + PPI Nifedipine (Brand) + PPI
Hide Arm/Group Description:

1 x 60 mg Nifedipine extended-release tablet

NIFEdipine 60 MG: Test Drug

SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology

1 x 60 mg PROCARDIA XL (nifedipine) extended-release tablet

NIFEdipine 60 MG: Reference Drug

SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology

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

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

Overall Number of Participants Analyzed 59 59 59 59
Mean (Standard Deviation)
Unit of Measure: hr
8.59  (33.15) 11.29  (82.39) 8.10  (32.64) 12.71  (119.78)
5.Secondary Outcome
Title Adverse Events
Hide Description Reported from the start of the first session to the follow-up visit.
Time Frame 66 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nifedipine (Generic) Nifedipine (Brand) Nifedipine (Generic) + PPI Nifedipine (Brand) + PPI
Hide Arm/Group Description:

1 x 60 mg Nifedipine extended-release tablet

NIFEdipine 60 MG: Test Drug

SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology

1 x 60 mg PROCARDIA XL (nifedipine) extended-release tablet

NIFEdipine 60 MG: Reference Drug

SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology

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

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

Overall Number of Participants Analyzed 59 59 59 59
Measure Type: Number
Unit of Measure: Events
37 19 51 38
Time Frame Approximately 2 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nifedipine (Generic) Nifedipine (Brand) Nifedipine (Generic) + PPI Nifedipine (Brand) + PPI
Hide Arm/Group Description

1 x 60 mg Nifedipine extended-release tablet

NIFEdipine 60 MG: Test Drug

SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology

1 x 60 mg PROCARDIA XL (nifedipine) extended-release tablet

NIFEdipine 60 MG: Reference Drug

SmartPill (TM): Gastric pH measurement using SmartPill (TM) Technology

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

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

All-Cause Mortality
Nifedipine (Generic) Nifedipine (Brand) Nifedipine (Generic) + PPI Nifedipine (Brand) + PPI
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/59 (0.00%)   0/59 (0.00%)   0/59 (0.00%)   0/59 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Nifedipine (Generic) Nifedipine (Brand) Nifedipine (Generic) + PPI Nifedipine (Brand) + PPI
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/59 (0.00%)   0/59 (0.00%)   0/59 (0.00%)   0/59 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nifedipine (Generic) Nifedipine (Brand) Nifedipine (Generic) + PPI Nifedipine (Brand) + PPI
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   23/59 (38.98%)   15/59 (25.42%)   38/59 (64.41%)   28/59 (47.46%) 
Gastrointestinal disorders         
Constipation   1/59 (1.69%)  1/59 (1.69%)  5/59 (8.47%)  2/59 (3.39%) 
Nausea   1/59 (1.69%)  0/59 (0.00%)  5/59 (8.47%)  2/59 (3.39%) 
Vomiting   1/59 (1.69%)  0/59 (0.00%)  3/59 (5.08%)  2/59 (3.39%) 
Nervous system disorders         
Headache   20/59 (33.90%)  14/59 (23.73%)  25/59 (42.37%)  22/59 (37.29%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Minori Kinjo
Organization: USFDA
Phone: 240-40269118
EMail: minori.kinjo@fda.hhs.gov
Layout table for additonal information
Responsible Party: Food and Drug Administration (FDA)
ClinicalTrials.gov Identifier: NCT03100838     History of Changes
Other Study ID Numbers: RIHSC 16-070D
First Submitted: March 29, 2017
First Posted: April 4, 2017
Results First Submitted: September 6, 2018
Results First Posted: July 22, 2019
Last Update Posted: August 16, 2019