A Bioequivalence Study Comparing Pirfenidone Tablet and Capsule Dosage Forms in Healthy Adult Participants



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:8/3/2016
Start Date:August 2015
End Date:August 2015

Use our guide to learn which trials are right for you!

A Phase I, Open-Label, Randomized, Four-Treatment Period, Four-Sequence, Single-Dose, Crossover, Pharmacokinetic Bioequivalence Study Comparing Pirfenidone Tablet and Capsule Dosage Forms in Healthy Adult Volunteers

This is a Phase I, open-label, randomized, four-treatment period, four-sequence,
single-dose, crossover pharmacokinetic study to determine the bioequivalence of pirfenidone
after administration of tablet and capsule dosage forms under both fed and fasted
conditions.


Inclusion Criteria:

- Participants between 18 and 55 years of age, inclusive, at the time of screening

- Participants of body mass index of 18.5-30.0 kilograms per square meter (kg/m^2),
inclusive

- Participants of reproductive potential must be willing to use reliable contraceptive
methods

Exclusion Criteria:

- Participants with significant medical history or unstable hepatic, pulmonary,
metabolic, neurologic, cardiovascular, gastrointestinal, hematologic, or psychiatric
systems, in the opinion of the investigator that may alter the absorption,
metabolism, or elimination of study drug

- Participants with calculated creatinine clearance rate less than (<) 30 milliliters
per minute (mL/min) (calculated using the Cockcroft-Gault equation) at screening

- Participants with any use of, or intent to use, medications, including prescription,
over-the-counter, herbal preparations, or vitamin/mineral supplementation other than
study medications from 14 days before screening through the follow-up telephone call
(except for contraception purpose)

- Participants who have received fluvoxamine therapy within 28 days before screening

- Participants who have received any medications known to chronically alter drug
absorption, metabolism, or elimination processes within 28 days of screening, or
participants who are taking drugs known to affect liver function, in the opinion of
the Sponsor or investigator

- Participants who have taken investigative drug and/or device in another clinical
study within 28 days or within the investigational drug 5 half-lives, whichever is
longer, before screening

- Participants previously dosed in any pirfenidone clinical study

- Participants with any hypersensitivity or idiosyncratic reaction to pirfenidone or
the constituents of pirfenidone

- Participants with any elevation of liver test results (alanine aminotransferase
[ALT], aspartate aminotransferase [AST], gamma-glutamyl transferase [GGT], direct
bilirubin, or alkaline phosphatase above the upper limit of normal)

- Participants with the following hemoglobin levels at screening: males < 13.5 grams
per deciliter (g/dL), females < 11.5 g/dL

- Females with a positive serum pregnancy test or who are breastfeeding

- Participants who are seropositive for hepatitis B surface antigen, hepatitis C virus
antibodies, or human immunodeficiency (HIV) antibodies at screening

- Participants who have a clinically significant abnormal electrocardiogram (ECG) at
screening or a Fridericia corrected QT interval (QTcF) greater than (>) 500
milliseconds (ms) at screening

- Participants with a plasma donation within 28 days before screening or with a
donation of blood or blood products or significant blood loss within 56 days before
screening

- Participants with poor venous access

- Participants who have used cigarettes (including vapor cigarettes), cigars, and
nicotine-containing products within 3 months before screening or plan to use them
through completion of the follow-up telephone call

- Participants with a history of alcoholism or drug abuse, per discretion of the
investigator, within 2 years of screening or a positive qualitative drug screen for
drugs of abuse at screening or Day -1

- Participants who have not withheld alcoholic beverages/alcohol-containing products or
caffeinated beverages/caffeine- or xanthine-containing products at least 72 hours
before first study dose administration or who plan to consume them during the study
or a positive qualitative drug screen for alcohol at screening or Day -1

- Participants with an abnormal diet (as determined by the investigator) within the 28
days before first study dose administration

- Participants who have not withheld consuming cruciferous vegetables (broccoli, kale,
Brussels sprouts), grapefruit or grapefruit juice, or chargrilled meat 48 hours
before dosing or who plan to consume them during the study

- Participants who cannot refrain from strenuous exercise from 48 hours before first
study dose administration through completion of the study
We found this trial at
1
site
?
mi
from
Merritt Island, FL
Click here to add this to my saved trials