Healthy
Conditions
Keywords
Healthy volunteer, Japanese males, homo-EM, Bioequivalence study
Brief summary
The purpose of the study is to determine whether the HPMC capsule of D961H 40 mg is bioequivalent to gelatine capsules of D961H 40 mg after a steady state is reached on Day 5
Interventions
DRUGD961H
Oral gelatin capsule
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy Japanese * Classified as homo-EM * Negative for HIV, Hepatitis B, Hepatitis C and syphilis
Exclusion criteria
* Significant clinical illness from 2 weeks preceding the pre-entry visit to the randomization * Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Confirm the HPMC capsule of D961H 40 mg is bioequivalent to the gelatin capsule of D961H 40 mg by assessment of area under the plasma concentration-time curve at steady state on Day 5 | PK sample at Day 5 of treatment period 1 and treatment period 2 |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the PK properties of HPMC capsule of D961H 40 mg following repeated oral doses, by assessment of plasma concentrations, mean residence time, time to maximum plasma concentration and half-life on Day 5 | PK sample on Day 5 of treatment period 1 and treatment period 2 |
| Evaluate the safety and tolerability of HPMC capsule of D961H 40 mg by assessment of AEs, clinical lab tests, ECG, vital signs. | Pre-entry, Day 5 of treatment period 1 and treatment period 2 and follow up (5-7 days after last dose) |
Countries
Japan
Outcome results
None listed