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NCT02851095 · ClinicalTrials.gov registry record · Phase 1

A Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release (XR) With Respect to Metformin XR Tablet Coadministered With Canagliflozin in Healthy Fed and Fasted Participants

A Phase 1 study of Healthy, sponsored by Janssen Research & Development.

Completed
Registry status
Phase 1
Development phase
44
Enrollment target
1
Study location

NCT02851095 is a Phase 1 study of Healthy that has completed, run by Janssen Research & Development. The registered enrollment target is 44 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02851095, a Phase 1 study of Healthy, has completed, sponsored by Janssen Research & Development.

COMPLETED
Registry status
Phase 1
Development phase
44 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to evaluate bioequivalence of the metformin component of the Fixed Dose Combination (FDC) tablet compared with the metformin Extended Release (XR) tablets co-administered with canagliflozin in healthy fed and fasted participants.

Conditions Studied

Healthy

Interventions

  • DRUG Canagliflozin
  • DRUG Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC]
  • DRUG Metformin Extended Release (XR)

Study Locations (1)

Nebraska

  • - Lincoln

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2016-08
Est. Completion 2016-11
Phase Phase 1

Sponsor

Janssen Research & Development

593 total trials

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What the Registry Record Tells You About NCT02851095

The ClinicalTrials.gov registry entry for NCT02851095 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (93% lower). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 3 interventions - of which Canagliflozin is the first listed.

NCT02851095 reports 1 study location spanning 1 distinct geographic area - top geographies include Nebraska.

Frequently Asked Questions

What is clinical trial NCT02851095 about?

NCT02851095 is a clinical study titled "A Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release (XR) With Respect to Metformin XR Tablet Coadministered With Canagliflozin in Healthy Fed and Fasted Participants". The purpose of this study is to evaluate bioequivalence of the metformin component of the Fixed Dose Combination (FDC) tablet compared with the metformin Extended Release (XR) tablets co-administered with canagliflozin in healthy fed and fasted participants.

What is the current status of trial NCT02851095?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2016-08. Estimated completion is 2016-11.

What conditions does trial NCT02851095 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT02851095?

The interventions under investigation include: Canagliflozin (DRUG), Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC] (DRUG), Metformin Extended Release (XR) (DRUG).

Who is sponsoring clinical trial NCT02851095?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02851095 being conducted?

This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.