The objective of this study was to compare pharmacokinetic of Lansoprazole Capsules 30 mg with Lansoprazole Capsules of Takeda 30 mg in healthy adult human subjects.
i. randomized, open label, single-dose, two-treatment, three-period,partial replicate pharmacokinetic study of Lansoprazole 30 mg Capsules of Beijing Sihuan Pharm, comparing with that of Lansoprazole enteric-coated Capsules 30 mg of Takeda Pharmaceutical Company Limited in healthy, adult, human subjects under fasting conditions. ii. randomized, open label, single dose, two-period, pharmacokinetic study of Lansoprazole 30 mg Capsules of Beijing Sihuan Pharm in healthy, adult, human subjects under fasting/fed conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Test 1: 30 healthy volunteers will be included and randomized into 3 groups (10 for each). During the study session, subjects will receive a single dose of Lansoprazole capsules 30 mg in sequence of T-R-R in group A; R-T-R in group B; and R-R-T in group C. Test 2: 12 healthy volunteers will be recruited and randomized to 2 groups (6 for each). Subjects in group A will receive a single dose of experimental drug in sequence of fast-fed condition; while in group B, subjects will receive the same dose and drug but in fed-fast order.
First affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, China
Pharmacokinetics Assessment
1. Cmax: Maximum Observed Plasma Concentration for lansoprazole Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. \[Time Frame: 16 hours post-dose on Day 1\] 2. TmaxTime to Reach the Maximum Plasma Concentration \[Time Frame: 16 hours post-dose on Day 1\] 3. AUC(0-inf): Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for lansoprazole AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity \[Time Frame: Time Frame: 16 hours post-dose on Day 1\] 4. AUC(0-16h): Area Under the Plasma Concentration-Time Curve From Time 0 to 36 hours Postdose for lansoprazoleAUC(0-36h) is measure of area under the plasma concentration and time curve from Time 0 to 36 hours postdose. \[Time Frame: 16 hours post-dose on Day 1\] model.
Time frame: 16 hrs post-dose on day 1.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.