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

Mylan

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: 1: Liothyronine Sodium Tablets; Drug: 2: Cytomel® Tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT00978055

LIOT-0592

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

31 participants in 2 patient groups

1

Experimental group

Description:

Liothyronine Sodium Tablets, 50 mcg

Treatment:

Drug: 1: Liothyronine Sodium Tablets

2

Active Comparator group

Description:

Cytomel® Tablets, 50 mcg

Treatment:

Drug: 2: Cytomel® Tablets