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Fasting Study of Levothyroxine Sodium Tablets 300 mcg to Synthroid® Tablets 300 mcg

NCT00648882 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2024-04-24

No results posted yet for this study

Summary

The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine sodium 300 mcg tablets to Abbott's Synthroid® 300 mcg tablets following a single, oral 600 mcg dose (2 × 300 mcg) administered under fasting conditions.

Conditions

  • Healthy

Interventions

DRUG

LEVOTHYROXINE SODIUM TABLETS,

2x300mcg, single dose fasting

DRUG

SYNTHROID® 300 mcg Tablets

2x300mcg, single dose fasting

Sponsors & Collaborators

  • Mylan Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • Alan K Copa, Pharm. D. · PRACS Institute Ltd. - Cetero Research

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2007-04-30
Completion
2007-05-31

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 NCT00648882 on ClinicalTrials.gov