ClinicalTrials.Veeva

Menu

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

Mylan logo

Mylan

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Topamax® Sprinkle Capsule 25 mg
Drug: Topiramate Sprinkle Capsules 25 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT00649740
TOPR-0583

Details and patient eligibility

About

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 administered under fasting conditions.

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

36 participants in 2 patient groups

1
Experimental group
Description:
Topiramate Sprinkle Capsules 25 mg
Treatment:
Drug: Topiramate Sprinkle Capsules 25 mg
2
Active Comparator group
Description:
Topamax® Sprinkle Capsule 25 mg
Treatment:
Drug: Topamax® Sprinkle Capsule 25 mg

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems