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NCT01101646 · ClinicalTrials.gov registry record · Phase 1

A Pharmacokinetic and Relative Bioavailability Study With Rabeprazole Sodium in Healthy Adult Volunteers

A Phase 1 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

Completed
Registry status
Phase 1
Development phase
36
Enrollment target

NCT01101646: Completed Phase 1 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

NCT01101646 is a Phase 1 study that has completed, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01101646, a Phase 1 study, has completed, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

COMPLETED
Registry status
Phase 1
Development phase
36 participants
Enrollment target

Study Summary

The purpose of the study is to evaluate and compare the pharmacokinetics (blood levels) of 2 different formulations, assess the effect of food on the pharmacokinetics and assess safety of rabeprazole sodium in healthy volunteers. Rabeprazole sodium is a drug used to treat patients with Gastro Esophageal Reflux Disease (GERD). GERD is a condition in which the esophagus (tube from throat to stomach) becomes irritated or inflamed because of acid backing up from the stomach.

Interventions

  • DRUG rabeprazole sodium

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2008-08
Est. Completion 2008-09
Phase Phase 1

What the finished NCT01101646 record still lists

NCT01101646 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).

The record links to 0 conditions, and to 1 intervention - of which rabeprazole sodium is the first listed.

NCT01101646 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01101646 about?

NCT01101646 is a clinical study titled "A Pharmacokinetic and Relative Bioavailability Study With Rabeprazole Sodium in Healthy Adult Volunteers". The purpose of the study is to evaluate and compare the pharmacokinetics (blood levels) of 2 different formulations, assess the effect of food on the pharmacokinetics and assess safety of rabeprazole sodium in healthy volunteers. Rabeprazole sodium is a drug used to treat patients with Gastro Esopha...

What is the current status of trial NCT01101646?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2008-08. Estimated completion is 2008-09.

What interventions are being tested in trial NCT01101646?

The interventions under investigation include: rabeprazole sodium (DRUG).

Who is sponsoring clinical trial NCT01101646?

This trial is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01101646's enrollment target sits among peer trials

36 1210th of 2000 higher than 743 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01101646, the US trial registry maintained by the National Library of Medicine. NCT01101646 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.