The objective of this research is to check whether the test drug (lamivudine in the form of coated tablet 150 mg) achieves plasma levels equivalent to those obtained from the EPIVIR in the form of coated tablet 150 mg GlaxoSmithKline administered to 28 volunteers of both genres under fasting condition.
It is an open, randomized, crossover 2x2, single dose, with the administration of medicine with 28 healthy volunteers, adults aged 18-50 years, of both genders (14 males and 14 females). Of the 28 volunteers planned in the study protocol to start, gave up one (woman) before the start of Phase I. So the study was initiated and completed with the participation of 27 volunteers. The volunteers were in hospital for a period of approximately 36 hours in each stage.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
28
Bioequivalence lamivudine 150 mg tablets fasting condition
Bioequivalence lamivudine 150 mg tablets fasting condition
AUClast
Area under the Plasma concentration-time curve from time Zero to last time (AUCinf) of lamivudine in plasma.
Time frame: Up to 36 hours
Cmax
Maximum concentration (Cmax) of lamivudine in plasma.
Time frame: Up to 36 hours
Tmax
Time for Maximum concentration (Tmax) of lamivudine in plasma.
Time frame: Up to 36 hours
T1/2
Terminal half-time of lamivudine in plasma.
Time frame: Up to 72 hours
AUCinf
Area under the Plasma concentration-time curve from time Zero to infinity (AUCinf) of lamivudine in plasma.
Time frame: Up to 36 hours
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