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

Mylan Pharmaceuticals Inc31 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

1: Liothyronine Sodium TabletsDRUG

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

2: Cytomel® TabletsDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

PRACS Institute, Ltd.

Fargo, North Dakota, United States

Outcomes

Primary Outcomes

Bioequivalence

Time frame: within 30 days

Data from ClinicalTrials.gov

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