Healthy
Conditions
Brief summary
An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of AK-R215
Detailed description
An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the safety and pharmacokinetics characteristics after administration of fixed dose combination or loose combination of AK-R215 in healthy adult male or menopausal female volunteers
Interventions
DRUGAK-R215
Investigational product is prescribed to all ofrandomized subjects
Investigational product is prescribed to all of randomized subjects
DRUGCholecalciferol 800IU
Investigational product is prescribed to all of randomized subjects
Sponsors
Alvogen Korea
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* BW is above 50kg and BMI is between 18.5 and 30.0 * Subject who agreed and signed on informed consent form prior to the study participation
Exclusion criteria
* Presence or history of clinically significant disease * Treatment history of any drug which might affect IP within 10days * History of other study drugs within 12weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-t | 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h |
| Cmax | 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h |
Secondary
| Measure | Time frame |
|---|---|
| Tmax | 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h |
| AUCinf, | 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h |
| T1/2 | 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h |
Countries
South Korea
Outcome results
None listed