NCT00649467

CompletedPhase 1

Applesauce Study of Topiramate Sprinkle Capsules 25 mg and T...

Mylan Pharmaceuticals Inc Source

ClinicalTrials.gov

Compare

Other study identifiers

Sponsor study identifier

TOPR-0585

Study Type

interventional

Actual enrollment (reported)

35

Locations

1 country

Sites

1

Timeline

Study Start

November 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2005

Actual (reported)

Study Completion

December 2005

Actual (reported)

Brief Summary

The objective of this study was to investigate the bioequivalence of Mylan's topiramate sprinkle 25 mg capsule to Ortho-McNeil's Topamax® Sprinkle 25 mg capsule following a single, oral 25 mg (1 x 25 mg) dose sprinkled on one teaspoon of applesauce under fasting conditions.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 35 participants
Study completion date: December 2005
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
November 2005
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
December 2005
Actual (reported)
Study Completion
December 2005
Actual (reported)
First Submitted
March 30, 2008
Actual (reported)
First Posted
April 1, 2008
Actual (reported)

Last Updated: April 23, 2024
Status Verified: April 2024
Last Update Submitted: April 22, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.
blood collections through 144 hours

Study Arms (2)

1

EXPERIMENTAL

Topiramate Sprinkle Capsules 25 mg

Drug: Topiramate Sprinkle Capsules 25 mg

2

ACTIVE COMPARATOR

Topamax® Sprinkle Capsules 25 mg

Drug: Topamax® Sprinkle Capsules 25 mg

Interventions

Topiramate Sprinkle Capsules 25 mgDrug

25mg, single dose applesauce

1

Topamax® Sprinkle Capsules 25 mgDrug

25mg, single dose applesauce

2

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

healthy, adult subjects, 18 years and older
able to swallow medication

You may not qualify if:

Sponsors & Collaborators

Mylan Pharmaceuticals Inc
Industrylead

Study Sites (1)

Kendle International Inc.

Morgantown, West Virginia, 26505, United States

Study Officials

Dorian Williams, M.D.
Kendle International Inc.
PRINCIPAL INVESTIGATOR

Enrollment

35 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: OTHER
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

March 30, 2008

First Posted

April 1, 2008

Study Start

November 2005

Date type not reported

This date has not been verified as actual or estimated.

NCT00649805

Fasting Applesauce Study of Verapamil HCl Extended-Release Capsules 300 mg and Verelan® PM Extended-Release Capsules 300 mg

Phase 1Completed

NCT01020214

Fasting Study of Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg and Benicar HCT® Tablets 40 mg/25 mg

Phase 1Completed

NCT01019590

Fed Study of Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg and Benicar HCT® Tablets 40 mg/25 mg

Phase 1Completed

NCT00650208

Fasting Study of Lamotrigine Tablets 25 mg to Lamictal® Tablets 25 mg

Phase 1Completed

NCT00647751

Food Study of Lamotrigine Tablets 25 mg to Lamictal® Tablets 25 mg

Phase 1Completed

NCT00648063

Fasting Study of Letrozole Tablets 2.5 mg and Femara® Tablets 2.5 mg

Phase 1Completed

institutionalized subjects
history of any significant disease
use of any prescription or OTC medications within 14 days of start of study
received any investigational products within 30 days prior to start of study

Contact the study team to confirm eligibility.

Primary Completion

December 2005

Actual (reported)

Study Completion

December 2005

Actual (reported)

Last Updated

April 23, 2024

Record last verified: 2024-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00649467
Data provider: ClinicalTrials.gov
Source updated: 2024-04-23
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:23:30 UTC

Locations

US(1)

Applesauce Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mg

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations