Bioequivalence Study of Levomerc 500 mg Tablets
BABE
BABE
Sponsor study identifier
interventional
24
1 country
1
Study Start
July 11, 2012
Actual (reported)Primary Completion
July 20, 2012
Actual (reported)Study Completion
September 20, 2012
Actual (reported)An open Label, Randomized, Two Way Cross over, Two Period, Two Treatment, two Sequence Bioequivalence Study of Levomerc tablets (Levofloxacin) 500 mg compared with Tavanic (Levofloxacin) 500 mg Tablet as reference drug in healthy Pakistani subjects under fasting condition.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 20, 2012
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 11, 2012
Actual (reported)July 20, 2012
Actual (reported)September 20, 2012
Actual (reported)April 14, 2022
Actual (reported)April 21, 2022
Actual (reported)maximum plasma concentration
maximum drug concentration in plasma after dose
up to 24 hours post dose
Time to reach maximum plasma concentration
Time required for the drug to reach maximum plasma concentration
0 to 24 hours post dose
AUC
Area under the time versus plasma drug concentration curve
0-2 4hours
Levomerc (Levofloxacin) tablets 500 mg
Tavanic (Levofloxacin) tablets 500 mg
A single dose consisting of one tablet of either test drug (Levomerc 500 mg) or reference drug (Tavanic 500mg) administered to each of the subjects in both Period.
Center for Bioequivalence Studies and clinical research (CBSCR), ICCBS
Karachi, Sindh, 75270, Pakistan
Prof. Dr. Muhammad R Shah, PhD
CBSCR, ICCBS, University of Karachi
Naghma Hashmi (Co-PI), PhD
CBSCR, ICCBS, University of Karachi
24 participants (actual enrollment reported by the registry).
First Submitted
April 14, 2022
First Posted
April 21, 2022
Study Start
July 11, 2012
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
July 20, 2012
Actual (reported)Study Completion
September 20, 2012
Actual (reported)Last Updated
September 7, 2022
Record last verified: 2022-09
Individual participant data (IPD) will only be available to other researchers upon reasonable request to PI keeping the participants' confidentiality intact.
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Source: ClinicalTrials.gov.
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