Healthy VolunteersPhase 1NCT03100838

Drug Interaction With Proton Pump Inhibitors for Nifedipine ER Tablets

A Phase 1 study testing Nifedipine 60 MG Extended Release Oral Tablet, omeprazole/sodium bicarbonate and SmartPill (TM) in people with Healthy Volunteers, run by Food and Drug Administration (FDA) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Nifedipine 60 MG Extended Release Oral Tablet, omeprazole/sodium bicarbonate and SmartPill (TM)
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteUnited States
Study dates: 20 Mar 2017to 6 Apr 2018
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy, males and non-pregnant female volunteers, 18 to 55 years of age, inclusive.
Smoking status: Only non-tobacco/nicotine users (for at least 6 months prior to the clinical study) will be eligible to participate in this study.
BMI that is within 18.5-35.0 kg/m², inclusive.
Healthy, according to the medical history, ECG, vital signs, laboratory results and physical examination as determined by the PI/Sub-Investigator.
Ability to comprehend and be informed of the nature of the study, as assessed by BPSI staff. Capable of giving written informed consent prior to receiving any study procedure. Must be able to communicate effectively with clinic staff.
Ability to fast for at least 14 hours.

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Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements.
Female subjects must fulfill at least one of the following:
Be surgically sterile for a minimum of 6 months;
Post-menopausal for a minimum of 1 year;
Agree to avoid pregnancy and use medically acceptable method of contraception from at least 30 days prior to the study until 30 days after the study has ended (last study procedure).
Medically acceptable methods of contraception include non-hormonal contraceptives, intrauterine device, or double barrier method (condom with foam or vaginal spermicidal suppository, diaphragm with spermicide). Complete abstinence alone can be used as a method of contraception.

Who cannot join

Known history or presence of any clinically significant hepatic, renal/genitourinary, gastrointestinal (e.g., gastrointestinal obstruction, gastrointestinal ulcers), cardiovascular (e.g., severe obstructive coronary artery disease, myocardial infarction, angina, heart failure), cerebrovascular, pulmonary, endocrine, immunological, musculoskeletal, neurological, psychiatric, dermatological or hematological disease or condition unless determined as not clinically significant by the PI/Sub-Investigator.
Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel disease), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting, swallowing disorder), or other conditions known to interfere with the absorption, distribution, metabolism or excretion of the drug experienced within 7 days prior to first dosing, as determined by the PI/Sub-Investigator.
QTc interval > 430 milliseconds for males and > 450 milliseconds for females, unless deemed otherwise by the PI/Sub-Investigator.
Abnormal clinical laboratory values, unless values are deemed by the PI/Sub-Investigator as "Not Clinically Significant".
Hemoglobin values less than 11.5 g/dl.
Abnormal vital signs (blood pressure [BP], heart rate [HR], respiratory rate [RR] and temperature) measurements, unless deemed otherwise by the PI/Sub-Investigator.

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Presence of any clinically significant illness within 30 days prior to first dosing, as determined by the PI/Sub-Investigator.
Presence of any significant physical or organ abnormality as determined by the PI/Sub-Investigator.
Individuals who have implanted or portable electro-mechanical medical device such as a cardiac pacemaker, defibrillator or infusion pump.
A positive test result for any of the following: HIV, Hepatitis B surface antigen, Hepatitis C, drugs of abuse (marijuana, amphetamines, barbiturates, cocaine, opiates, phencyclidine and benzodiazepines), alcohol test and cotinine. Positive pregnancy test for female subjects.
Known history or presence of:
Alcohol abuse or dependence within one year prior to first study period;
Drug abuse or dependence;
Hypersensitivity or idiosyncratic reaction to nifedipine, omeprazole/sodium bicarbonate, its excipients, and/or related substances;
Hypotension;
Bartter's syndrome;
Gastric bezoar;
Crohn's disease or diverticulitis;
severe dysphagia to food or pills;
Food allergies and/or presence of any dietary restrictions;
Severe allergic reactions (e.g. anaphylactic reactions, angioedema).
History of intolerance to and/or difficulty with blood sampling through venipuncture.
Abnormal diet patterns (for any reason) during the four weeks preceding the study, including fasting, high protein diets, vegan, etc.
Individuals who have donated, in the days prior to first study period:
50-499 mL of blood in the previous 30 days;
500 mL or more in the previous 56 days.
Donation of plasma by plasmapheresis within 7 days prior to first study period.
Individuals who have participated in another clinical trial or who received an investigational drug within 30 days prior to first study period.
Use of any enzyme-modifying drugs and/or other products, including strong inhibitors of cytochrome P450 (CYP) enzymes (e.g. cimetidine, fluoxetine, quinidine, fluconazole, ketoconazole, voriconazole, itraconazole, clarithromycin, erythromycin, nefazodone, atazanavir, saquinavir, indinavir, and nelfinavir) and strong inducers of CYP enzymes (e.g. barbiturates, carbamazepine, glucocorticoids, phenytoin, St. John´s Wort and rifampin) in the previous 30 days before first study period.
Use of drugs such as, proton pump inhibitors, clopidogrel, tacrolimus, digoxin, cyclosporine, disulfiram, benzodiazepines, diazepam, warfarin, methotrexate, iron salts, erlotinib, and mycophenolate mofetil (MMF) in the previous 30 days before first study period, or individuals with vitamin B-12 deficiency (as long-term dosing (more than 3 years) of omeprazole/sodium bicarbonateZegerid may lead to vitamin B-12 deficiency)
Individuals having undergone gastrointestinal (GI) surgery within 3 months prior to first study period, unless deemed otherwise by PI/Sub-Investigator.
Use of any prescription medication within 14 days prior to first study period (except for contraceptives).
Use of any over-the-counter medications (including oral multivitamins, herbal and/or dietary supplements and/or teas) within 14 days prior to first study period (except for spermicidal/barrier contraceptive products).
Consumption of food or beverages containing grapefruit and grapefruit juice and/or pomelo within 10 days prior to first study period.
Consumption of food or beverages containing caffeine/methylxanthines, poppy seeds and/or alcohol within 48 hours before dosing.
Use of diuretics (drugs or food, see Appendix D) within 24 hours before dosing of SmartPillTM.
Individuals having undergone any major surgery within 6 months prior to the start of the study, unless deemed otherwise by PI/Sub-Investigator.
Difficulty with swallowing whole tablets or large capsules.
Have had a tattoo or body piercing within 30 days prior to first study period and during the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

BioPharma Services Inc.
Columbia, Missouri, 65201

Other trials in United States

About this study

Official title: A Single-Dose, Open-label, Randomized, Crossover, Drug-Drug Interaction Study of Nifedipine Extended-release Tablets With or Without Multiple-dose Administration of Proton-Pump Inhibitor Omeprazole/Sodium Bicarbonate in Healthy Volunteers

The purpose of this study is to measure the amount of study drug present in blood after being administered a generic version of nifedipine extended-release tablets, 60 mg (Valeant Pharmaceuticals, LLC) and brand-name version PROCARDIA XL extended-release tablets, 60 mg (Pfizer Inc.) individually and in presence of stomach acid reducing drug (antacid), omeprazole/sodium bicarbonate capsules, 40 mg/1100 mg (generic) on separate occasions, on an empty stomach. This study also involves administrations of an FDA-cleared capsule, SmartPill™, which will measure stomach acid, prior to each study arm.

Read the detailed description

A question that arises with generic oral extended-release (ER) products is related to pH-dependent dissolution kinetics in comparison with that of their reference listed drug (RLD). For example, poorly water-soluble drugs with the presence of pKa in the gastrointestinal (GI) pH range have pH-dependent solubility and dissolution behaviors during in vivo drug release. In this case, the generic product which utilizes a different release mechanism could amplify or reduce such a pH dependence (e.g. osmotic pump RLD vs. matrix generic counterparts). This may render these generic ER products more or less dependent on gastric pH modification, commonly occurred in patients taking concomitant over-the-counter (OTC) proton pump inhibitors (PPIs) for the treatment of gastric acid-related disorders. It has been noted that PPIs (e.g. lansoprazole, omeprazole, esomeprazole) and PPIs with antacids (e.g. omeprazole/sodium bicarbonate) can drastically elevate the gastric pH, thus potentially changing the equilibrium solubility of co-administered drug substances or altering their release profiles.

For instance, nifedipine is a calcium channel blocker, indicated for the long-term treatment of hypertension and angina. The drug substance is a weak acid (pKa 3.9) and practically insoluble in water. Currently, there is one RLD of oral ER nifedipine tablets based on an osmotic pump design (Procardia XL) and a generic counterpart of ER nifedipine tablets employing a matrix formulation design which is different from this RLD product. Due to complicated release mechanisms, quality attribute profiles, and in vivo pharmacokinetics (PK) behaviors of ER products, FDA is assessing the need of a drug-drug interaction study between PPIs/antacids (e.g. omeprazole/sodium bicarbonate) and generic nifedipine ER products based on a formulation design which is different from that of its RLD.

To this end, the objective of this proposal is to investigate the dependence of in vivo PK on the formulation design of generic oral extended-release products in comparison with that of their RLD when co-administered with PPIs/antacids. The outcome of this study will help the Agency advance further understanding about product PK performance in potential patient population with abnormal gastric pH and improve review standards for equivalence of this category of oral ER products if necessary. The study results will help the Agency gain a better understanding of drug-drug interaction between oral modified-release products and PPIs/antacids and establish regulatory standards of bioequivalence approaches for this category of generic oral ER products.

Conditions: Healthy Volunteers
Being tested: Nifedipine 60 MG Extended Release Oral Tablet, omeprazole/sodium bicarbonate, SmartPill (TM)
Keywords: Proton Pump Inhibitor, Bioequivalence, Drug-Drug Interaction, Modified Release, Nifedipine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nifedipine 60 MG Extended Release Oral TabletDrug
Also called Procardia XL
Reference Drug (Brand)
Nifedipine 60 MG Extended Release Oral TabletDrug
Test Drug (Generic)
omeprazole/sodium bicarbonateDrug
Proton Pump Inhibitor/Antacid for drug-drug interaction
SmartPill (TM)Device
Gastric pH measurement using SmartPill (TM) Technology

Study groups in NCT03100838
Study group	Role	What they receive
Nifedipine (Generic)	Experimental	1 x 60 mg Nifedipine extended-release tablet Receives: Drug: Nifedipine 60 MG Extended Release Oral Tablet; Device: SmartPill (TM)
Nifedipine (Brand)	Active comparator	1 x 60 mg PROCARDIA XL (nifedipine) extended-release tablet Receives: Drug: Nifedipine 60 MG Extended Release Oral Tablet; Device: SmartPill (TM)
Nifedipine (Generic) + PPI	Active comparator	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 Receives: Drug: Nifedipine 60 MG Extended Release Oral Tablet; Drug: omeprazole/sodium bicarbonate; Device: SmartPill (TM)
Nifedipine (brand) + PPI	Active comparator	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 Receives: Drug: Nifedipine 60 MG Extended Release Oral Tablet; Drug: omeprazole/sodium bicarbonate; Device: SmartPill (TM)

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Plasma Concentration (Cmax)
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.
Measured: 48 hours
Time at Maximum Plasma Concentration (Tmax)
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.
Measured: 48 hours
Area Under the Concentration (AUC 0-t)
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.
Measured: 48 hours
Half-life
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.
Measured: 48 hours

Secondary outcomes (1)

Adverse Events
Reported from the start of the first session to the follow-up visit.
Measured: 66 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Mar 20176 Apr 2018

First posted4 Apr 2017
Study start20 Mar 2017
Primary completion23 Dec 2017
Study completion6 Apr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Model description: A single-dose, randomized, open-label, drug-drug interaction (DDI), 4-way crossover, four-treatment, four-sequence, bioequivalence study
Masking: None (open label)
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03100838
Sponsor's protocol ID: RIHSC 16-070D
Status last verified: Aug 2019
First submitted: 29 Mar 2017
Last updated: 16 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided: We do not have the plans to share the de-identified IPD at this time.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Dose, Open-label, Randomized, Crossover, Drug-Drug Interaction Study of Nifedipine Extended-release Tablets With or Without Multiple-dose Administration of Proton-Pump Inhibitor Omeprazole/Sodium Bicarbonate in Healthy Volunteers
ClinicalTrials.gov ID: NCT03100838
Acronym / sponsor ID: RIHSC 16-070D
Conditions: Healthy Volunteers
Keywords: Proton Pump Inhibitor, Bioequivalence, Drug-Drug Interaction, Modified Release, Nifedipine
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Food and Drug Administration (FDA)US federal agency
Collaborators: BioPharma Services Inc.
Study start: 20 Mar 2017 (actual)
Primary completion: 23 Dec 2017 (actual)
Study completion: 6 Apr 2018 (actual)
First posted: 4 Apr 2017 (actual)
Results: Posted 22 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4
Model description: A single-dose, randomized, open-label, drug-drug interaction (DDI), 4-way crossover, four-treatment, four-sequence, bioequivalence study

Arm	Type	Receives
Nifedipine (Generic)	Experimental	Drug: Nifedipine 60 MG Extended Release Oral Tablet, Device: SmartPill (TM)1 x 60 mg Nifedipine extended-release tablet
Nifedipine (Brand)	Active comparator	Drug: Nifedipine 60 MG Extended Release Oral Tablet, Device: SmartPill (TM)1 x 60 mg PROCARDIA XL (nifedipine) extended-release tablet
Nifedipine (Generic) + PPI	Active comparator	Drug: Nifedipine 60 MG Extended Release Oral Tablet, Drug: omeprazole/sodium bicarbonate, Device: SmartPill (TM)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 (brand) + PPI	Active comparator	Drug: Nifedipine 60 MG Extended Release Oral Tablet, Drug: omeprazole/sodium bicarbonate, Device: SmartPill (TM)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

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (12 listed)

Healthy, males and non-pregnant female volunteers, 18 to 55 years of age, inclusive.
Smoking status: Only non-tobacco/nicotine users (for at least 6 months prior to the clinical study) will be eligible to participate in this study.
BMI that is within 18.5-35.0 kg/m², inclusive.
Healthy, according to the medical history, ECG, vital signs, laboratory results and physical examination as determined by the PI/Sub-Investigator.
Ability to comprehend and be informed of the nature of the study, as assessed by BPSI staff. Capable of giving written informed consent prior to receiving any study procedure. Must be able to communicate effectively with clinic staff.

Key exclusion criteria (39 listed)

Known history or presence of any clinically significant hepatic, renal/genitourinary, gastrointestinal (e.g., gastrointestinal obstruction, gastrointestinal ulcers), cardiovascular (e.g., severe obstructive coronary artery disease, myocardial infarction, angina, heart failure), cerebrovascular, pulmonary, endocrine, immunological, musculoskeletal, neurological, psychiatric, dermatological or hematological disease or condition unless determined as not clinically significant by the PI/Sub-Investigator.
Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel disease), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting, swallowing disorder), or other conditions known to interfere with the absorption, distribution, metabolism or excretion of the drug experienced within 7 days prior to first dosing, as determined by the PI/Sub-Investigator.
QTc interval > 430 milliseconds for males and > 450 milliseconds for females, unless deemed otherwise by the PI/Sub-Investigator.
Abnormal clinical laboratory values, unless values are deemed by the PI/Sub-Investigator as "Not Clinically Significant".
Hemoglobin values less than 11.5 g/dl.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nifedipine 60 MG Extended Release Oral TabletAlso: Procardia XLReference Drug (Brand)	Drug	Nifedipine (Brand), Nifedipine (brand) + PPI
Nifedipine 60 MG Extended Release Oral TabletTest Drug (Generic)	Drug	Nifedipine (Generic), Nifedipine (Generic) + PPI
omeprazole/sodium bicarbonateProton Pump Inhibitor/Antacid for drug-drug interaction	Drug	Nifedipine (Generic) + PPI, Nifedipine (brand) + PPI
SmartPill (TM)Gastric pH measurement using SmartPill (TM) Technology	Device	Nifedipine (Brand), Nifedipine (Generic), Nifedipine (Generic) + PPI, Nifedipine (brand) + PPI

Primary outcome

Maximum Plasma Concentration (Cmax)
Time frame: 48 hours
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 at Maximum Plasma Concentration (Tmax)
Time frame: 48 hours
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.
Area Under the Concentration (AUC 0-t)
Time frame: 48 hours
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.
Half-life
Time frame: 48 hours
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.

1 secondary outcome

Adverse Events
Time frame: 66 days

Results and safety

Results posted to the registry on 22 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1 (ABCD)	16	14
Sequence 2 (BCDA)	16	14
Sequence 3 (CDAB)	16	14
Sequence 4 (DABC)	16	15

Primary outcome: Maximum Plasma Concentration (Cmax)

Time frame: 48 hours. Mean (Standard Deviation). Unit: ng/mL

Measure	Nifedipine (Generic) n = 59	Nifedipine (Brand) n = 59	Nifedipine (Generic) + PPI n = 57	Nifedipine (Brand) + PPI n = 55
Value	94.37 (42.42)	43.84 (44.07)	106.35 (43.67)	51.65 (32.47)

Primary outcome: Time at Maximum Plasma Concentration (Tmax)

Time frame: 48 hours. Mean (Full Range). Unit: hr

Measure	Nifedipine (Generic) n = 59	Nifedipine (Brand) n = 59	Nifedipine (Generic) + PPI n = 59	Nifedipine (Brand) + PPI n = 59
Value	4 (2 to 16)	16 (3 to 36)	6 (3 to 24)	16 (5 to 36.02)

Primary outcome: Area Under the Concentration (AUC 0-t)

Time frame: 48 hours. Mean (Standard Deviation). Unit: ng.h/mL

Measure	Nifedipine (Generic) n = 59	Nifedipine (Brand) n = 59	Nifedipine (Generic) + PPI n = 59	Nifedipine (Brand) + PPI n = 59
Value	1166.21 (45.64)	1061.49 (47.52)	1514.83 (29.95)	1239.26 (40.68)

Primary outcome: Half-life

Time frame: 48 hours. Mean (Standard Deviation). Unit: hr

Measure	Nifedipine (Generic) n = 59	Nifedipine (Brand) n = 59	Nifedipine (Generic) + PPI n = 59	Nifedipine (Brand) + PPI n = 59
Value	8.59 (33.15)	11.29 (82.39)	8.10 (32.64)	12.71 (119.78)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Approximately 2 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nifedipine (Generic)	0 of 59 (0%)	23 of 59 (39%)	0 of 59
Nifedipine (Brand)	0 of 59 (0%)	15 of 59 (25.4%)	0 of 59
Nifedipine (Generic) + PPI	0 of 59 (0%)	38 of 59 (64.4%)	0 of 59
Nifedipine (Brand) + PPI	0 of 59 (0%)	28 of 59 (47.5%)	0 of 59

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided. We do not have the plans to share the de-identified IPD at this time.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kathleen Doisy principal investigator

BioPharma Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Plasma Concentration (Cmax) (time frame: 48 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03100838.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2019.