Bioavailability Study of BIA 5-453
Comparative Bioavailability Study of BIA 5-453 Under Fasted and Fed Conditions
Comparative Bioavailability Study of BIA 5-453 Under Fasted and Fed Conditions
Sponsor study identifier
interventional
12
1 country
1
Study Start
July 15, 2008
Actual (reported)Primary Completion
August 14, 2008
Actual (reported)Study Completion
August 14, 2008
Actual (reported)The purpose of this study was to compare the bioavailability and tolerability of BIA 5-453 under fasted and fed conditions.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 14, 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 15, 2008
Actual (reported)August 14, 2008
Actual (reported)August 14, 2008
Actual (reported)March 20, 2017
Actual (reported)March 27, 2017
Actual (reported)Cmax - the maximum plasma concentration
pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose
Tmax - the time of occurrence of Cmax
pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose
AUC0-t - the area under the plasma concentration-time curve from time zero to the last sampling time
pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose
AUC0-∞ - the area under the plasma concentration versus time curve from time zero to infinity
pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose
BIA 5-453 200 mg in fasting conditions
BIA 5-453 200 mg in fed conditions
BIA 5-453 capsules 50 mg. Route of administration: Oral. In one period subjects received 4 capsules of 50 mg of BIA 5-453 after a fasting of at least 10 hours, and in the other period subjects were dosed with 4 capsules of 50 mg of BIA 5-453 after a standard high-fat and high-calorie meal
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Biotrial's Human Pharmacology Unit
Rennes, F-35000, France
12 participants (actual enrollment reported by the registry).
First Submitted
March 20, 2017
First Posted
March 27, 2017
Study Start
July 15, 2008
Actual (reported)Absorption, Distribution, Metabolism and Excretion of [14C]- Labeled BIA 5-453 and Metabolites
Contact the study team to confirm eligibility.
Primary Completion
August 14, 2008
Actual (reported)Study Completion
August 14, 2008
Actual (reported)Last Updated
March 27, 2017
Record last verified: 2017-03
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Source: ClinicalTrials.gov.
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