A Phase 1 Drug Drug Interaction Clinical Trial of C1-R215 and C2-R215 in Healthy Male Volunteers

Study Overview
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Brief Summary
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Randomized, open-label, single-dose, three-treatment, six-sequence, three-way crossover study to evaluate the safety and pharmacokinetic characteristics after coadministration of C1-R215 and C2-R215 compared to the administration of C1-R215 and C2-R215 independently in healthy male volunteers

Official Title
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A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Coadministration of C1-R215 and C2-R215 Compared to the Administration of C1-R215 and C2-R215 Independently in Healthy Male Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Treatment B
* Drug: Treatment C
* Drug: Treatment BC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male between 19 and 45 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
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

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 |
| --- | --- |
| Active Comparator: Group A<br>Period 1: Bazedoxifene 20 mg Period 2: Cholecalciferol granule 10 mg Period 3: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg | Drug: Treatment B<br>* Bazedoxifene 20 mg<br>* Other names: Bazedoxifene 20 mg;Drug: Treatment C<br>* Cholecalciferol granule 10 mg<br>* Other names: Cholecalciferol granule 10 mg;Drug: Treatment BC<br>* Bazedoxifene 20 mg, Cholecalciferol granule 10 mg<br>* Other names: Bazedoxifene 20 mg, Cholecalciferol granule 10 mg;|
| Active Comparator: Group B<br>Period 1: Bazedoxifene 20 mg Period 2: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 3: Cholecalciferol granule 10 mg | Drug: Treatment B<br>* Bazedoxifene 20 mg<br>* Other names: Bazedoxifene 20 mg;Drug: Treatment C<br>* Cholecalciferol granule 10 mg<br>* Other names: Cholecalciferol granule 10 mg;Drug: Treatment BC<br>* Bazedoxifene 20 mg, Cholecalciferol granule 10 mg<br>* Other names: Bazedoxifene 20 mg, Cholecalciferol granule 10 mg;|
| Active Comparator: Group C<br>Period 1: Cholecalciferol granule 10 mg Period 2: Bazedoxifene 20 mg Period 3: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg | Drug: Treatment B<br>* Bazedoxifene 20 mg<br>* Other names: Bazedoxifene 20 mg;Drug: Treatment C<br>* Cholecalciferol granule 10 mg<br>* Other names: Cholecalciferol granule 10 mg;Drug: Treatment BC<br>* Bazedoxifene 20 mg, Cholecalciferol granule 10 mg<br>* Other names: Bazedoxifene 20 mg, Cholecalciferol granule 10 mg;|
| Active Comparator: Group D<br>Period 1: Cholecalciferol granule 10 mg Period 2: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 3: Bazedoxifene 20 mg | Drug: Treatment B<br>* Bazedoxifene 20 mg<br>* Other names: Bazedoxifene 20 mg;Drug: Treatment C<br>* Cholecalciferol granule 10 mg<br>* Other names: Cholecalciferol granule 10 mg;Drug: Treatment BC<br>* Bazedoxifene 20 mg, Cholecalciferol granule 10 mg<br>* Other names: Bazedoxifene 20 mg, Cholecalciferol granule 10 mg;|
| Active Comparator: Group E<br>Period 1: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 2: Cholecalciferol granule 10 mg Period 3: Bazedoxifene 20 mg | Drug: Treatment B<br>* Bazedoxifene 20 mg<br>* Other names: Bazedoxifene 20 mg;Drug: Treatment C<br>* Cholecalciferol granule 10 mg<br>* Other names: Cholecalciferol granule 10 mg;Drug: Treatment BC<br>* Bazedoxifene 20 mg, Cholecalciferol granule 10 mg<br>* Other names: Bazedoxifene 20 mg, Cholecalciferol granule 10 mg;|
| Active Comparator: Group F<br>Period 1: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 2: Bazedoxifene 20 mg Period 3: Cholecalciferol granule 10 mg | Drug: Treatment B<br>* Bazedoxifene 20 mg<br>* Other names: Bazedoxifene 20 mg;Drug: Treatment C<br>* Cholecalciferol granule 10 mg<br>* Other names: Cholecalciferol granule 10 mg;Drug: Treatment BC<br>* Bazedoxifene 20 mg, Cholecalciferol granule 10 mg<br>* Other names: Bazedoxifene 20 mg, Cholecalciferol granule 10 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve(AUCt) of Bazedoxifene |  | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h | 
| Area under the plasma concentration versus time curve(AUCt) of Cholecalciferol |  | -24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h | 
| Peak plasma concentration(Cmax) of Bazedoxifene |  | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h | 
| Peak plasma concentration(Cmax) of Cholecalciferol |  | -24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h |