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

NCT00978055 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2009-09-16

No results posted yet for this study

Summary

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.

Conditions

  • Healthy

Interventions

DRUG

1: Liothyronine Sodium Tablets

Liothyronine Sodium Tablets, 50 mcg 2 x 50 mcg, single-dose, fasting

DRUG

2: Cytomel® Tablets

Cytomel® Tablets, 50 mcg 2 x 50 mcg, single-dose, fasting

Sponsors & Collaborators

  • Mylan Pharmaceuticals Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00978055 on ClinicalTrials.gov