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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2010-12-20 |
| Est. Completion | 2011-02-03 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗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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Read our methodology - how this data is sourced, computed, and verified.
Related
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