CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 64 enrolled
Drug / intervention
Nifedipine 60 MG Extended Release Oral Tablet +3 moredrug
Likely dose
Nifedipine 60 MG Extended Release Oral Tabletfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03100838
NCT03100838Phase 1Completed
CompareCT.gov

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

Food and Drug Administration (FDA)·interventional·Posted Apr 4, 2017·Updated Aug 16, 2019

In Brief

A Phase 1 clinical trial evaluating Nifedipine 60 MG Extended Release Oral Tablet, omeprazole/sodium bicarbonate, and 1 other intervention for Healthy Volunteers. Completed, enrolled 64 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
CollaboratorsBioPharma Services Inc.

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 4, 2017
Enrollment StartMar 20, 2017
Primary CompletionDec 23, 2017
Study CompletionApr 6, 2018
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 9.2 years ago

Interventions

Nifedipine 60 MG Extended Release Oral Tabletdrug

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