Fasting Study of Liothyronine Sodium Tablets (50 Mcg) to Cytomel® Tablets (50 Mcg)
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ClinicalTrials.gov Identifier: NCT00978055 |
Recruitment Status :
Completed
First Posted : September 16, 2009
Last Update Posted : September 16, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: 1: Liothyronine Sodium Tablets Drug: 2: Cytomel® Tablets | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 31 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Official Title: | Single-Dose Fasting Bioequivalence Study of Liothyronine Sodium Tablets (50 Mcg; Mylan) to Cytomel® Tablets (50 Mcg; King) in Healthy Euthyroid Adult Volunteers |
Study Start Date : | October 2007 |
Actual Primary Completion Date : | December 2007 |
Actual Study Completion Date : | December 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Liothyronine Sodium Tablets, 50 mcg
|
Drug: 1: Liothyronine Sodium Tablets
Liothyronine Sodium Tablets, 50 mcg 2 x 50 mcg, single-dose, fasting |
Active Comparator: 2
Cytomel® Tablets, 50 mcg
|
Drug: 2: Cytomel® Tablets
Cytomel® Tablets, 50 mcg 2 x 50 mcg, single-dose, fasting |
- Bioequivalence [ Time Frame: within 30 days ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00978055
United States, North Dakota | |
PRACS Institute, Ltd. | |
Fargo, North Dakota, United States, 58104 |
Responsible Party: | Wayne Talton, Mylan, Inc. |
ClinicalTrials.gov Identifier: | NCT00978055 |
Other Study ID Numbers: |
LIOT-0592 |
First Posted: | September 16, 2009 Key Record Dates |
Last Update Posted: | September 16, 2009 |
Last Verified: | September 2009 |