Fasting Study of Liothyronine Sodium Tablets (50 Mcg) to Cytomel® Tablets (50 Mcg)
Phase 1
Completed
- Conditions
- Healthy
- Registration Number
- NCT00978055
- Lead Sponsor
- Mylan Pharmaceuticals Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Bioequivalence within 30 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
PRACS Institute, Ltd.
🇺🇸Fargo, North Dakota, United States