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OpenTrials
Completed

NCT Number: NCT00978055

Fasting Study of Liothyronine Sodium Tablets (50 Mcg) to Cytomel® Tablets (50 Mcg)

The objective of this study was to investigate the bioequivalence of Mylan's liothyronine sodium 50 mcg tablets to King's Cytomel® 50 mcg tablets following a single, oral 100 mcg (2 x 50 mcg) dose administration under fasting conditions.

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Key information

Conditions

Healthy

Age range

18 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 males and/or non-pregnant, non-lactating females, 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 prior to start of study
  • received any investigational products within 30 days prior to start of study

Treatment and study plan

1: Liothyronine Sodium Tablets

Drug

Liothyronine Sodium Tablets, 50 mcg

2 x 50 mcg, single-dose, fasting

2: Cytomel® Tablets

Drug

Cytomel® Tablets, 50 mcg

2 x 50 mcg, single-dose, fasting

Primary outcomes

  1. Bioequivalence

    Time frame: within 30 days

Sponsors and collaborators

Lead sponsor

Mylan Pharmaceuticals Inc

Industry

Registry information

Official study title

Single-Dose Fasting Bioequivalence Study of Liothyronine Sodium Tablets (50 Mcg; Mylan) to Cytomel® Tablets (50 Mcg; King) in Healthy Euthyroid Adult Volunteers

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Sep 16, 2009
Registry last updated
Sep 16, 2009

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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