Healthy
Conditions
Brief summary
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.
Interventions
Single 45 mg dose; Dosage form is capsule taken orally.
Single 45 mg dose; Dosage form is capsule taken orally.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male subjects and/or female subjects with no physical possibility of getting pregnant. * Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study. * Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion criteria
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease. * Any condition possibly affecting drug absorption (eg, gastrectomy). * A positive urine drug screen. * History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening. * Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) preceding the first dose of study medication. * Pregnant females; breastfeeding females; females with physical possibility of getting pregnant .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the Concentration-Time Curve (AUC) from time zero extrapolate to infinite time | 7 days | AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] | 7 days | AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t) |
| Maximum Observed Plasma Concentration (Cmax) | 2 days | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | 2 days | — |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 7 days | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) |
| Plasma Decay Half-Life (t1/2) | 7 days | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. |
| Apparent Volume of Distribution (Vz/F) | 7 days | 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. |
| Area under the Concentration-Time Curve (AUC) from 0 to 72 | 3 days | AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. |
| Apparent Oral Clearance (CL/F) | 7 days | 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. |
Countries
United States
Outcome results
None listed