Subjects and study design
Eligible study participants were healthy male subjects aged between 18
to 45 years with a BMI of 18.5 to 30.0 kg/m2. An
informed consent form was obtained from all the study participants and
the study was conducted in accordance with the Declaration of Helsinki
and ICH-GCP guidelines. Important exclusion criteria included known
hypersensitivity to 6MP, presence of TMPT polymorphisms, and consumption
of xanthine-containing products. One-week preceding entry into the
study. The study was designed as an open-label, balanced, randomized,
single-dose, two-treatment, two-sequence, two-period, cross-over study
(Figure 1). The test formulation was powder for oral suspension (PFOS)
of 6MP 10 mg/mL (Dose: 5ml=50 mg) manufactured by IDRS Labs Private
Ltd., India. The reference formulation was, Mercaptopurine USP tablets
50 mg (Dose: 50mg). The sample size was estimated to be 54 and eligible
subjects were randomized using SAS 9.4 (North Carolina, United States).
A 7-day washout interval was allowed between the two periods to ensure
complete elimination of the administered drug. Subjects were fasted
overnight for at least 10 hours before the scheduled time of dosing. A
single oral dose of 5 mL of Oral Suspension i.e., Test Product (T) was
administered orally using a graduated syringe in sitting posture and one
tablet of the reference product (R) was administered orally with 240 mL
of water.