NCT00649467

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Nov 2005

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 1, 2008

Completed
Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

1 month

First QC Date

March 30, 2008

Last Update Submit

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

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:

  • 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.

Sponsors & Collaborators

Study Sites (1)

Kendle International Inc.

Morgantown, West Virginia, 26505, United States

Location

Related Links

Study Officials

  • Dorian Williams, M.D.

    Kendle International Inc.

    PRINCIPAL INVESTIGATOR

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 1, 2005

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

April 23, 2024

Record last verified: 2024-04

Locations

US(1)