None listed
Conditions
Brief summary
This study is designed as a Phase I trial to evaluate the pharmacokinetic profile of different pharmaceutical formulations(capsules and tablets) and doses (200 mg and 267 mg) of pirfenidone administered orally to 32 healthy adult volunteers.
Interventions
32 healthy participants will be randomly allocated, in a four-way cross-over fashion, to receive a single dose of the following oral treatments:
Treatment A: one capsule containing 200 mg pirfenidone
Treatment B: one capsule containing 200 mg pirfenidone without excipients (pure pirfenidone)
Treatment C: one tablet containing 200 mg pirfenidone
Treatment D: one capsule containing 267 mg pirfenidone
Each treatment will be administered orally with 240 ml of water.
There will be a washout period o
32 healthy participants will be randomly allocated, in a four-way cross-over fashion, to receive a single dose of the following oral treatments: Treatment A: one capsule containing 200 mg pirfenidone Treatment B: one capsule containing 200 mg pirfenidone without excipients (pure pirfenidone) Treatment C: one tablet containing 200 mg pirfenidone Treatment D: one capsule containing 267 mg pirfenidone Each treatment will be administered orally with 240 ml of water. There will be a washout period of 7 days between all treatments Participants will be required to fast overnight (for at least 10 hours) before dosing and for 4 hours thereafter.
Sponsors
AFT Pharmaceuticals Ltd.
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy subjects, males and females aged 18 to 50 years of age. Females must be sterile or using adequate contraception. Participants must not have taken any prescription medications for at least 14 days or over-the-counter medications for at least 7 days before the start of each study phase, with the exception of oral contraceptives and the study medication. All subjects must be deemed healthy on the basis of a medical history, physical exam (including vital signs and ECG recording), urinalysis, and blood biochemical and haematological examinations.
Exclusion criteria
1.Women who are pregnant or nursing. 2. Women of childbearing potential who are unwilling to take adequate contraceptive precautions, i.e., a hormonal contraceptive, an intrauterine device, double-barrier method, or abstinence. A woman of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone a partial or total hysterectomy or surgical sterilisation, e.g. bilateral tubal ligation, bilateral oophorectomy. 3. Women of childbearing potential who are unwilling to undergo a urine pregnancy test. 4. Have an alcohol intake in excess of 14 units per week for females and 21 units per week for males. 5. Have a history of drug abuse or positive test results for drug abuse during screening. 6. Unwilling to abstain from smoking throughout the whole duration of the study 7. Unable and refuse to abstain the used prescription drugs (not including oral contraceptives) within 14 days prior to study drug administration or have used over-the-counter drugs or herbal products within 7 days prior to study drug administration.
Outcome results
None listed