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OpenTrials
Completed

NCT Number: NCT00649493

Fed Study of Rabeprazole Sodium Tablets 20 mg and Aciphex® Tablets 20 mg

The objective of this study was to investigate the bioequivalence of Mylan's rabeprazole sodium 20 mg tablets to Eisai's Aciphex® 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administration under fed conditions.

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Key information

Conditions

Healthy

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRACS Institute, Ltd.

Fargo, North Dakota, 58104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rabeprazole Sodium Tablets 20 mg

Drug

20mg, single dose fed

Aciphex® Tablets 20 mg

Drug

20mg, single dose fed

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.

    Time frame: blood collections through 24 hours

Sponsors and collaborators

Lead sponsor

Mylan Pharmaceuticals Inc

Industry

Registry information

Official study title

Single-Dose Food In Vivo Bioequivalence Study of Rabeprazole Sodium Tablets (20 mg; Mylan) and Aciphex® Tablets (20 mg; Eisai) in Healthy Volunteers

Important dates

Study start
2003
Primary completion
2003
Study completion
2003
First posted
Apr 1, 2008
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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