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NCT01161966 · ClinicalTrials.gov registry record · Phase 1

Bioequivalence Study of Zonisamide Capsules 100 mg of Dr.Reddy's Laboratories Limited Under Fasting 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

NCT01161966 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.

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The verdict

NCT01161966, 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 fasted subjects.

Conditions Studied

Healthy

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

Sponsor

Dr. Reddy's Laboratories Limited

52 total trials

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What the Registry Record Tells You About NCT01161966

The ClinicalTrials.gov registry entry for NCT01161966 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.

NCT01161966 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT01161966 about?

NCT01161966 is a clinical study titled "Bioequivalence Study of Zonisamide Capsules 100 mg of Dr.Reddy's Laboratories Limited Under Fasting 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 fasted subjects.

What is the current status of trial NCT01161966?

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 NCT01161966 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT01161966?

The interventions under investigation include: Zonisamide (DRUG), Zonegran (DRUG).

Who is sponsoring clinical trial NCT01161966?

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

Where is trial NCT01161966 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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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.