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NCT03282838 · ClinicalTrials.gov registry record · Phase 1

Study on the Pharmacokinetics (PK) of DFN-15 vs Comparator and Food-effect on DFN-15 PK in Healthy Adult Subjects

A Phase 1 study, sponsored by Dr. Reddy's Laboratories Limited.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target

NCT03282838 is a Phase 1 study that has completed, run by Dr. Reddy's Laboratories Limited. The registered enrollment target is 24 participants.

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The verdict

NCT03282838, a Phase 1 study, has completed, sponsored by Dr. Reddy's Laboratories Limited.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target

Study Summary

An Open-Label, Three-Way Randomized, Single Dose Crossover Study Comparing Bioavailability of DFN-15 under fasting conditions versus Comparator under fed conditions and to determine food-effect of DFN-15 in Healthy Adult Subjects

Interventions

  • DRUG DFN-15 (fasted)
  • DRUG DFN-15 (fed)
  • DRUG Comparator Celebrex® (fed)

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2017-06-09
Est. Completion 2018-01-12
Phase Phase 1

Sponsor

Dr. Reddy's Laboratories Limited

52 total trials

What the Registry Record Tells You About NCT03282838

The ClinicalTrials.gov registry entry for NCT03282838 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dr. Reddy's Laboratories Limited, which has 52 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which DFN-15 (fasted) is the first listed.

NCT03282838 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03282838 about?

NCT03282838 is a clinical study titled "Study on the Pharmacokinetics (PK) of DFN-15 vs Comparator and Food-effect on DFN-15 PK in Healthy Adult Subjects". An Open-Label, Three-Way Randomized, Single Dose Crossover Study Comparing Bioavailability of DFN-15 under fasting conditions versus Comparator under fed conditions and to determine food-effect of DFN-15 in Healthy Adult Subjects

What is the current status of trial NCT03282838?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2017-06-09. Estimated completion is 2018-01-12.

What interventions are being tested in trial NCT03282838?

The interventions under investigation include: DFN-15 (fasted) (DRUG), DFN-15 (fed) (DRUG), Comparator Celebrex® (fed) (DRUG).

Who is sponsoring clinical trial NCT03282838?

This trial is sponsored by Dr. Reddy's Laboratories Limited, which has 52 total clinical trials registered on ClinicalTrials.gov.

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.