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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00978055

Enrollment

Registered

2009-09-16

Start date

2007-10-31

Completion date

2007-12-31

Last updated

2009-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief 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.

Interventions

DRUG1: Liothyronine Sodium Tablets

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

DRUG2: Cytomel® Tablets

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Bioequivalence	within 30 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026