AK-R215 Pharmacokinetic Study Phase I

Study Overview
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Brief Summary
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An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of AK-R215

Detailed Description
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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

Official Title
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AK-R215 Pharmacokinetic Study Pharmacokinetic Characteristics of AK-R215 in Comparison to Each Component Coadministered in Healthy Adult Male or Menopausal Female Valunteers.

Conditions
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Healthy

Intervention / Treatment
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* Drug: AK-R215
* Drug: Bazedoxifene 20 mg
* Drug: Cholecalciferol 800IU


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A group<br>AK-R215, test drug | Drug: AK-R215<br>* Investigational product is prescribed to all ofrandomized subjects<br>Drug: Bazedoxifene 20 mg<br>* Investigational product is prescribed to all of randomized subjects<br>Drug: Cholecalciferol 800IU<br>* Investigational product is prescribed to all of randomized subjects<br>|
| Active Comparator: B group<br>reference drug, Bazedoxifene 20mg, Cholecalciferol 800IU | Drug: AK-R215<br>* Investigational product is prescribed to all ofrandomized subjects<br>Drug: Bazedoxifene 20 mg<br>* Investigational product is prescribed to all of randomized subjects<br>Drug: Cholecalciferol 800IU<br>* Investigational product is prescribed to all of randomized subjects<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |