Fasting Study of Liothyronine Sodium Tablets (50 Mcg) to... | NCT00978055

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

NCT00978055

Sponsor

Mylan Pharmaceuticals Inc

Status

Completed

Last Update Posted

Sep 16, 2009Estimated

Enrollment

31Actual

Phase

Phase 1

Conditions

Healthy

Interventions

1: Liothyronine Sodium Tablets
2: Cytomel® Tablets

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Sep 15, 2009

First Submission Date that Met QC Criteria

Sep 15, 2009

First Posted Date

Sep 16, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 15, 2009

Last Update Posted Date

Sep 16, 2009Estimated

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Liothyronine Sodium Tablets, 50 mcg	Drug: 1: Liothyronine Sodium Tablets
2	Active Comparator	Cytomel® Tablets, 50 mcg	Drug: 2: Cytomel® Tablets

Interventions

Name	Type	Description	Arm Group Labels	Other Names
1: Liothyronine Sodium Tablets	Drug	Liothyronine Sodium Tablets, 50 mcg 2 x 50 mcg, single-dose, fasting	1

Measure	Description	Time Frame
Bioequivalence		within 30 days

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
PRACS Institute, Ltd.		Fargo	North Dakota	58104	United States