NCT03005340

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Dec 2016

Typical duration for phase_1 healthy

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

December 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

December 23, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 29, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

December 29, 2016

Status Verified

December 1, 2016

Enrollment Period

3 months

First QC Date

December 23, 2016

Last Update Submit

December 23, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (6)

Group A

ACTIVE COMPARATOR

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

Drug: Treatment BDrug: Treatment CDrug: Treatment BC

Group B

ACTIVE COMPARATOR

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

Drug: Treatment BDrug: Treatment CDrug: Treatment BC

Group C

ACTIVE COMPARATOR

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

Drug: Treatment BDrug: Treatment CDrug: Treatment BC

Group D

ACTIVE COMPARATOR

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

Drug: Treatment BDrug: Treatment CDrug: Treatment BC

Group E

ACTIVE COMPARATOR

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

Drug: Treatment BDrug: Treatment CDrug: Treatment BC

Group F

ACTIVE COMPARATOR

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

Drug: Treatment BDrug: Treatment CDrug: Treatment BC

Interventions

Treatment BDRUG

Bazedoxifene 20 mg

Also known as: Bazedoxifene 20 mg
Group AGroup BGroup CGroup DGroup EGroup F
Treatment CDRUG

Cholecalciferol granule 10 mg

Also known as: Cholecalciferol granule 10 mg
Group AGroup BGroup CGroup DGroup EGroup F
Treatment BCDRUG

Bazedoxifene 20 mg, Cholecalciferol granule 10 mg

Also known as: Bazedoxifene 20 mg, Cholecalciferol granule 10 mg
Group AGroup BGroup CGroup DGroup EGroup F

Eligibility Criteria

Age19 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

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

MeSH Terms

Interventions

bazedoxifene

Study Officials

  • Park

    Dong-A University Hospital

    PRINCIPAL INVESTIGATOR

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

December 23, 2016

First Posted

December 29, 2016

Study Start

December 1, 2016

Primary Completion

March 1, 2017

Study Completion

June 1, 2017

Last Updated

December 29, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share