Status:
COMPLETED
Fasting Study of Liothyronine Sodium Tablets (50 Mcg) to Cytomel® Tablets (50 Mcg)
Lead Sponsor:
Mylan Pharmaceuticals Inc
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 adm...
Eligibility Criteria
Inclusion
- healthy males and/or non-pregnant, non-lactating females, 18 years and older
- able to swallow medication
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00978055
Start Date
October 1 2007
End Date
December 1 2007
Last Update
September 16 2009
Active Locations (1)
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1
PRACS Institute, Ltd.
Fargo, North Dakota, United States, 58104