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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: Completed Phase 1 study of Healthy, sponsored by Dr. Reddy's Laboratories Limited.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 26 participants
Start Date 2005-01
Est. Completion 2005-03
Phase Phase 1
Dr. Reddy's Laboratories Limited

52 total trials

What the finished NCT01161979 record still lists

NCT01161979 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower).

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 a single indexed study location in 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.

Similar trials for Healthy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01161979's enrollment target sits among peer trials

26 760th of 1090 higher than 314 of 1,090 other Healthy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01161979, the US trial registry maintained by the National Library of Medicine. NCT01161979 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.