Single-Dose Food In Vivo Bioequivalence Study of Metoprolol Tartrate/Hydrochlorothiazide Tablets (100/50 mg; Mylan) to Lopressor HCT® Tablets (100/50 mg; Novartis) in Healthy Volunteers
Sponsor study identifier
interventional
32
1 country
1
Study Start
January 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2003
Actual (reported)Study Completion
February 2003
Actual (reported)The objective of this study was to investigate the bioequivalence of Mylan metoprolol tartrate/hydrochlorothiazide 100/50 mg tablets to Novartis Lopressor HCT® 100/50 mg tablets following a single, oral 100/50 mg (1 x 100/50 mg) dose administration under fed conditions.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2003
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2003
Date type not reportedThis date has not been verified as actual or estimated.
February 2003
Actual (reported)February 2003
Actual (reported)March 30, 2008
Actual (reported)April 1, 2008
Actual (reported)Bioequivalence
within 30 days
Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg
Lopressor HCT® Tablets 100/50 mg
100/50mg, single dose fed
100/50mg, single dose fed
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordPRACS Institute, Ltd.
Fargo, North Dakota, 58104, United States
James D Carlson, Pharm. D.
PRACS Institute Ltd.
32 participants (actual enrollment reported by the registry).
First Submitted
March 30, 2008
First Posted
April 1, 2008
Study Start
January 2003
Date type not reportedThis date has not been verified as actual or estimated.
Study of Sertraline Hydrochloride Tablets 100 mg and Zoloft® Tablets 100 mg
Contact the study team to confirm eligibility.
Primary Completion
February 2003
Actual (reported)Study Completion
February 2003
Actual (reported)Last Updated
April 24, 2024
Record last verified: 2024-04
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Source: ClinicalTrials.gov.
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