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Clinical Trials/NCT00978055
NCT00978055CompletedPhase 1

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

Mylan Pharmaceuticals Inc2 sites in 1 country31 target enrollmentStarted: October 2007Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
31
Locations
2
Primary Endpoint
Bioequivalence
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Bioequivalence

Time Frame: within 30 days

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry

Study Sites (2)

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