43264
document
Bioequivalence evaluation of a fixed dose combination lamivudine + stavudine tablet with concurrent administration of lamivudine tablet and stavudine capsule in healthy volunteers . The study was designed to compare the rate and extent of absorption of a fixed dose combination tablet of lamivudine ( CAS 134678-17-4 ) and stavudine ( CAS 3056-17-5 ) with the concurrent administration of lamivudine tablet and stavudine capsule in 24 healthy volunteers under fasting conditions . The volunteers were randomly assigned to the test or reference treatment , with the two treatment periods separated by a washout period of at least 7 days . Plasma samples were analyzed for both analytes lamivudine and stavudine by a validated analytical method . Since the 90 % confidence intervals for the " test/reference " mean ratio of the In-transformed pharmacokinetic variables C ( max ) AUC ( 0-t ) and AUC ( 0-infinity ) were clearly within the conventional bioequivalence range of 80 % to 125 % , the two treatments were considered bioequivalent . The safety profiles of both the test and reference formulations were comparable .
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Intervention_Pharmacological
lamivudine + stavudine
43266
Intervention_Pharmacological
lamivudine
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Intervention_Pharmacological
stavudine
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Intervention_Pharmacological
lamivudine ( CAS 134678-17-4 )
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Intervention_Pharmacological
stavudine ( CAS 3056-17-5 )
43270
Intervention_Pharmacological
lamivudine tablet
43271
Intervention_Pharmacological
stavudine capsule
43272
Intervention_Pharmacological
lamivudine
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Intervention_Pharmacological
stavudine
43274
Outcome_Physical
rate and extent of absorption
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Outcome_Physical
Plasma samples
43276
Outcome_Other
"
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Outcome_Physical
test/reference
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Outcome_Other
"
43279
Outcome_Physical
C ( max ) AUC ( 0-t ) and AUC ( 0-infinity )
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Outcome_Other
safety profiles
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Participant_Sample-size
24
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Participant_Condition
under fasting