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

NCT ID: NCT03005340

Last Updated: 2016-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-06-30

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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

Period 1: Bazedoxifene 20 mg Period 2: Cholecalciferol granule 10 mg Period 3: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg

Group Type ACTIVE_COMPARATOR

Treatment B

Intervention Type DRUG

Bazedoxifene 20 mg

Treatment C

Intervention Type DRUG

Cholecalciferol granule 10 mg

Treatment BC

Intervention Type DRUG

Bazedoxifene 20 mg, Cholecalciferol granule 10 mg

Group B

Period 1: Bazedoxifene 20 mg Period 2: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 3: Cholecalciferol granule 10 mg

Group Type ACTIVE_COMPARATOR

Treatment B

Intervention Type DRUG

Bazedoxifene 20 mg

Treatment C

Intervention Type DRUG

Cholecalciferol granule 10 mg

Treatment BC

Intervention Type DRUG

Bazedoxifene 20 mg, Cholecalciferol granule 10 mg

Group C

Period 1: Cholecalciferol granule 10 mg Period 2: Bazedoxifene 20 mg Period 3: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg

Group Type ACTIVE_COMPARATOR

Treatment B

Intervention Type DRUG

Bazedoxifene 20 mg

Treatment C

Intervention Type DRUG

Cholecalciferol granule 10 mg

Treatment BC

Intervention Type DRUG

Bazedoxifene 20 mg, Cholecalciferol granule 10 mg

Group D

Period 1: Cholecalciferol granule 10 mg Period 2: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 3: Bazedoxifene 20 mg

Group Type ACTIVE_COMPARATOR

Treatment B

Intervention Type DRUG

Bazedoxifene 20 mg

Treatment C

Intervention Type DRUG

Cholecalciferol granule 10 mg

Treatment BC

Intervention Type DRUG

Bazedoxifene 20 mg, Cholecalciferol granule 10 mg

Group E

Period 1: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 2: Cholecalciferol granule 10 mg Period 3: Bazedoxifene 20 mg

Group Type ACTIVE_COMPARATOR

Treatment B

Intervention Type DRUG

Bazedoxifene 20 mg

Treatment C

Intervention Type DRUG

Cholecalciferol granule 10 mg

Treatment BC

Intervention Type DRUG

Bazedoxifene 20 mg, Cholecalciferol granule 10 mg

Group F

Period 1: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 2: Bazedoxifene 20 mg Period 3: Cholecalciferol granule 10 mg

Group Type ACTIVE_COMPARATOR

Treatment B

Intervention Type DRUG

Bazedoxifene 20 mg

Treatment C

Intervention Type DRUG

Cholecalciferol granule 10 mg

Treatment BC

Intervention Type DRUG

Bazedoxifene 20 mg, Cholecalciferol granule 10 mg

Interventions

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Treatment B

Bazedoxifene 20 mg

Intervention Type DRUG

Treatment C

Cholecalciferol granule 10 mg

Intervention Type DRUG

Treatment BC

Bazedoxifene 20 mg, Cholecalciferol granule 10 mg

Intervention Type DRUG

Other Intervention Names

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Bazedoxifene 20 mg Cholecalciferol granule 10 mg Bazedoxifene 20 mg, Cholecalciferol granule 10 mg

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Alvogen Korea

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Park

Role: PRINCIPAL_INVESTIGATOR

Dong-A University Hospital

Other Identifiers

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AK-CTR215-I-01

Identifier Type: -

Identifier Source: org_study_id