Drug Interaction With Proton Pump Inhibitors for Nifedipine ER Tablets

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT03100838

Run by

Food and Drug Administration (FDA)

People needed

64

Starts

2017-03-20

Expected to finish

2018-04-06

Last updated by the study team

2019-08-16

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.
• 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.

You may not qualify if…

• 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.
• 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;

Where it is running

• BioPharma Services Inc. — Columbia, Missouri, United States

Full record on ClinicalTrials.gov

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