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AK-R215 Pharmacokinetic Study Phase I

NCT ID: NCT03321318

Last Updated: 2017-10-25

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

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-13

Study Completion Date

2018-01-12

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

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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A group

AK-R215, test drug

Group Type EXPERIMENTAL

AK-R215

Intervention Type DRUG

Investigational product is prescribed to all ofrandomized subjects

Bazedoxifene 20 mg

Intervention Type DRUG

Investigational product is prescribed to all of randomized subjects

Cholecalciferol 800IU

Intervention Type DRUG

Investigational product is prescribed to all of randomized subjects

B group

reference drug, Bazedoxifene 20mg, Cholecalciferol 800IU

Group Type ACTIVE_COMPARATOR

AK-R215

Intervention Type DRUG

Investigational product is prescribed to all ofrandomized subjects

Bazedoxifene 20 mg

Intervention Type DRUG

Investigational product is prescribed to all of randomized subjects

Cholecalciferol 800IU

Intervention Type DRUG

Investigational product is prescribed to all of randomized subjects

Interventions

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AK-R215

Investigational product is prescribed to all ofrandomized subjects

Intervention Type DRUG

Bazedoxifene 20 mg

Investigational product is prescribed to all of randomized subjects

Intervention Type DRUG

Cholecalciferol 800IU

Investigational product is prescribed to all of randomized subjects

Intervention Type DRUG

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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alvogen Korea

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dong-A University Hospital

Busan, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AK-CTR-215-I-02

Identifier Type: -

Identifier Source: org_study_id