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NCT01258530 · ClinicalTrials.gov registry record · Phase 1

A Study to Evaluate the Bioequivalence of Over-encapsulated Oseltamivir Capsules to Marketed Oseltamivir Capsules in Healthy Volunteers

A Phase 1 study of Influenza, Human, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 1
Development phase
28
Enrollment target
1
Study location

NCT01258530 is a Phase 1 study of Influenza, Human that has completed, run by GlaxoSmithKline. The registered enrollment target is 28 participants, below the 16,222-participant average among 18 other Influenza, Human trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01258530, a Phase 1 study of Influenza, Human, has completed, sponsored by GlaxoSmithKline.

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

Study Summary

This is a study in healthy adult volunteers to assess the bioequivalence of over-encapsulated oseltamivir capsules to commercially available oseltamivir capsules. Both formulations will be administered in the fasting state.

Conditions Studied

Interventions

  • DRUG over-encapsulated oseltamivir
  • DRUG oseltamivir

Study Locations (1)

New York

  • GSK Investigational Site - Buffalo

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2010-12-20
Est. Completion 2011-02-03
Phase Phase 1

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT01258530

The ClinicalTrials.gov registry entry for NCT01258530 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 16,222-participant average among 18 other Influenza, Human trials with a reported enrollment target (100% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Influenza, Human appearing as the primary indexed condition, and to 2 interventions - of which over-encapsulated oseltamivir is the first listed.

NCT01258530 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT01258530 about?

NCT01258530 is a clinical study titled "A Study to Evaluate the Bioequivalence of Over-encapsulated Oseltamivir Capsules to Marketed Oseltamivir Capsules in Healthy Volunteers". This is a study in healthy adult volunteers to assess the bioequivalence of over-encapsulated oseltamivir capsules to commercially available oseltamivir capsules. Both formulations will be administered in the fasting state.

What is the current status of trial NCT01258530?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2010-12-20. Estimated completion is 2011-02-03.

What conditions does trial NCT01258530 study?

This clinical trial studies the following conditions: Influenza, Human.

What interventions are being tested in trial NCT01258530?

The interventions under investigation include: over-encapsulated oseltamivir (DRUG), oseltamivir (DRUG).

Who is sponsoring clinical trial NCT01258530?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01258530 being conducted?

This trial has 1 study location across New York. 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.