This study is to investigate whether D961H sachet 20 mg is bioequivalent to D961H HPMC
capsule 20 mg following repeated oral doses, and to evaluate the safety and tolerability of
these two formulations in healthy male Japanese subjects.
Drug: D961H Sachet 20 mg
Drug: D961H HPMC capsule 20 mg
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Full eligibility criteria for NCT01595425
Ages eligible for Study
20 Years to 45 Years
Genders eligible for Study
Accepts Healthy Volunteers
Provision of signed and dated, written informed consent prior to any study specific procedures
Japanese healthy male subjects aged 20 to 45 years of age
Body Mass Index 19-27 kg/m2 and body weight 50-85 kg
Clinically normal findings
Classified as homo-EM(extensive metabolizers) according to the genotype of CYP2C19
Significant clinical illness
Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease
Clinical significant condition which could modify the absorption of the investigational product
Past or present severe allergic disease, hypersensitivity to food or drugs, or allergic symptoms requiring medical intervention
All locations for NCT01595425
Fukuoka-shi, Fukuoka, Japan
View full eligibility
Tris trial is registered with FDA with number: NCT01595425. The sponsor of the trial is AstraZeneca and it is looking for 71 volunteers for the current phase.
Official trial title: A Phase I, Open-label, Randomized, Single-center, 2-way Crossover Bioequivalence Study Comparing a Pellets Based Sachet Formulation of D961H 20 mg and a Commercial HPMC Capsule of D961H 20 mg After Repeated Oral Administration in Japanese Healthy Male Subjects
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