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NCT01161979 · ClinicalTrials.gov registry record · Phase 1
Bioequivalence Study of Zonisamide Capsules 100 mg of Dr.Reddy's Laboratories Limited Under Fed Conditions
A Phase 1 study of Healthy, sponsored by Dr. Reddy's Laboratories Limited.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT01161979 is a Phase 1 study of Healthy that has completed, run by Dr. Reddy's Laboratories Limited. The registered enrollment target is 26 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01161979, a Phase 1 study of Healthy, has completed, sponsored by Dr. Reddy's Laboratories Limited.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's Zonisamide 100 mg Capsule to that of Zonegran® 100 mg Capsule after a single, one-capsule dose in subjects fed a high standard fat meal.
Conditions Studied
Interventions
- DRUG Zonisamide
- DRUG Zonegran
Study Locations (1)
Florida
- SFBC Ft. Myers, Inc. - Fort Myers
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2005-01 |
| Est. Completion | 2005-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01161979
The ClinicalTrials.gov registry entry for NCT01161979 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 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 (96% lower). The listed sponsor is Dr. Reddy's Laboratories Limited, which has 52 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Zonisamide is the first listed.
NCT01161979 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT01161979 about?
NCT01161979 is a clinical study titled "Bioequivalence Study of Zonisamide Capsules 100 mg of Dr.Reddy's Laboratories Limited Under Fed Conditions". The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's Zonisamide 100 mg Capsule to that of Zonegran® 100 mg Capsule after a single, one-capsule dose in subjects fed a high standard fat meal.
What is the current status of trial NCT01161979?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2005-01. Estimated completion is 2005-03.
What conditions does trial NCT01161979 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT01161979?
The interventions under investigation include: Zonisamide (DRUG), Zonegran (DRUG).
Who is sponsoring clinical trial NCT01161979?
This trial is sponsored by Dr. Reddy's Laboratories Limited, which has 52 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01161979 being conducted?
This trial has 1 study location across Florida. 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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