Tacrolimus Capsule | Study Design

Tacrolimus Capsule – FDA – BE Study Design (NTI drug)

 

Regulatory Body FDA
Study Drug Information Test Product Reference Product
Strength Tacrolimus 5mg Prograf 5mg
Formulation Capsule Capsule
Manufacturer Any Sponsor/FDA Astellas Pharma
Route Oral Oral
Therapeutic Indication Calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney or heart transplants, in combination with other immune-suppressants

 

Study Profile
Study Phase Bioequivalence
Design 4-way fully replicate
Study Population Healthy male and non-pregnant female volunteers; 18 years old and above
No live vaccines at least 30 days prior to study administration and 30 days post last
tacrolimus dose.
Smoker Use No
BMI 18.5 – 30kg/m2
Hormonal Contraceptive No
Sample Size (# of Subjects) FA/FE:
– Covid-19 buffer: 70 subjects
– No covid-19 buffer: 66 subjects (minimum of 54 subjects for power of 80%)
Study Condition Fasting and Fed
*Note: For FDA study RFTOP#1222070, only fasting study is requested
In house Confinement -10 to 24 hours post dose
Washout 2 weeks
Dosing Schedule Single dose (1 x 5 mg)
PK sampling time points FA: Pre-dose and at 0.25, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and
72 hours post dose. (19 TPs)
FE: Pre-dose and at 0.5, 1, 2, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 12, 16, 24, 36, 48 and 72 hours
post dose (19 TPs)
Clinical Safety Monitoring • Vital sign (HR + BP): pre-dose and at 1, 2, 4, 6, 12 and exit at 24h post dose
• Temperature: screening, pre-dose and 6 and 12 hours post dose in every periods.TB skin test: Screening
• TB questionnaire: screening
• Hb and HCT: period 4 check-in
• Special Exclusive criteria:
o Not received live vaccine from screening to 30 days after study ended
*Dr. Dessouki confirmed on 12 Dec 2019.
Hours of PI Monitoring 4h

 

Analytical Details
Analyte(s) Tacrolimus
Analytical Method LC-MS/MS
Matrix Whole blood
Estimated Analytical Range 0.1 ng/mL – 100 ng/mL (validated)

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