NCT03321318

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jul 2017

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 13, 2017

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 25, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2018

Completed
Last Updated

October 25, 2017

Status Verified

October 1, 2017

Enrollment Period

2 months

First QC Date

July 19, 2017

Last Update Submit

October 22, 2017

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

A group

EXPERIMENTAL

AK-R215, test drug

Drug: AK-R215Drug: Bazedoxifene 20 mgDrug: Cholecalciferol 800IU

B group

ACTIVE COMPARATOR

reference drug, Bazedoxifene 20mg, Cholecalciferol 800IU

Drug: AK-R215Drug: Bazedoxifene 20 mgDrug: Cholecalciferol 800IU

Interventions

AK-R215DRUG

Investigational product is prescribed to all ofrandomized subjects

A groupB group
Bazedoxifene 20 mgDRUG

Investigational product is prescribed to all of randomized subjects

A groupB group
Cholecalciferol 800IUDRUG

Investigational product is prescribed to all of randomized subjects

A groupB group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dong-A University Hospital

Busan, South Korea

Location

MeSH Terms

Interventions

bazedoxifeneCholecalciferol

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2017

First Posted

October 25, 2017

Study Start

July 13, 2017

Primary Completion

September 18, 2017

Study Completion

January 12, 2018

Last Updated

October 25, 2017

Record last verified: 2017-10

Locations

KR(1)