The particle size of the active ingredient may impact dissolution rate in the gastro intestinal tract and hence the amount of drug available for absorption. Similarly, differences in the percentage of the excipients used in the formulated capsules may affect dissolution rate. The purpose of this study is to estimate the effect that particle size and percentage of excipients could have in drug absorption, which will improve the manufacturing process of the formulated capsules.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
Single 45 mg dose; Dosage form is capsule taken orally.
Single 45 mg dose; Dosage form is capsule taken orally.
Single 45 mg dose; Dosage form is capsule taken orally.
Single 45 mg dose; Dosage form is capsule taken orally.
Pfizer Investigational Site
New Haven, Connecticut, United States
Area under the Concentration-Time Curve (AUC) from time zero extrapolate to infinite time
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Time frame: 7 days
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
Time frame: 7 days
Maximum Observed Plasma Concentration (Cmax)
Time frame: 2 days
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time frame: 7 days
Area under the Concentration-Time Curve (AUC) from 0 to 72
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Time frame: 3 days
Apparent Oral Clearance (CL/F)
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Time frame: 7 days
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 2 days
Apparent Volume of Distribution (Vz/F)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Time frame: 7 days
Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time frame: 7 days
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