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

December 23, 2016 updated by: Alvogen Korea

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
Period 1: Bazedoxifene 20 mg Period 2: Cholecalciferol granule 10 mg Period 3: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg
Drug: Treatment B
Bazedoxifene 20 mg
Other Names:
  • Bazedoxifene 20 mg
Drug: Treatment C
Cholecalciferol granule 10 mg
Other Names:
  • Cholecalciferol granule 10 mg
Drug: Treatment BC
Bazedoxifene 20 mg, Cholecalciferol granule 10 mg
Other Names:
  • Bazedoxifene 20 mg, Cholecalciferol granule 10 mg
Active Comparator: Group B
Period 1: Bazedoxifene 20 mg Period 2: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 3: Cholecalciferol granule 10 mg
Drug: Treatment B
Bazedoxifene 20 mg
Other Names:
  • Bazedoxifene 20 mg
Drug: Treatment C
Cholecalciferol granule 10 mg
Other Names:
  • Cholecalciferol granule 10 mg
Drug: Treatment BC
Bazedoxifene 20 mg, Cholecalciferol granule 10 mg
Other Names:
  • Bazedoxifene 20 mg, Cholecalciferol granule 10 mg
Active Comparator: Group C
Period 1: Cholecalciferol granule 10 mg Period 2: Bazedoxifene 20 mg Period 3: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg
Drug: Treatment B
Bazedoxifene 20 mg
Other Names:
  • Bazedoxifene 20 mg
Drug: Treatment C
Cholecalciferol granule 10 mg
Other Names:
  • Cholecalciferol granule 10 mg
Drug: Treatment BC
Bazedoxifene 20 mg, Cholecalciferol granule 10 mg
Other Names:
  • Bazedoxifene 20 mg, Cholecalciferol granule 10 mg
Active Comparator: Group D
Period 1: Cholecalciferol granule 10 mg Period 2: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 3: Bazedoxifene 20 mg
Drug: Treatment B
Bazedoxifene 20 mg
Other Names:
  • Bazedoxifene 20 mg
Drug: Treatment C
Cholecalciferol granule 10 mg
Other Names:
  • Cholecalciferol granule 10 mg
Drug: Treatment BC
Bazedoxifene 20 mg, Cholecalciferol granule 10 mg
Other Names:
  • Bazedoxifene 20 mg, Cholecalciferol granule 10 mg
Active Comparator: Group E
Period 1: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 2: Cholecalciferol granule 10 mg Period 3: Bazedoxifene 20 mg
Drug: Treatment B
Bazedoxifene 20 mg
Other Names:
  • Bazedoxifene 20 mg
Drug: Treatment C
Cholecalciferol granule 10 mg
Other Names:
  • Cholecalciferol granule 10 mg
Drug: Treatment BC
Bazedoxifene 20 mg, Cholecalciferol granule 10 mg
Other Names:
  • Bazedoxifene 20 mg, Cholecalciferol granule 10 mg
Active Comparator: Group F
Period 1: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 2: Bazedoxifene 20 mg Period 3: Cholecalciferol granule 10 mg
Drug: Treatment B
Bazedoxifene 20 mg
Other Names:
  • Bazedoxifene 20 mg
Drug: Treatment C
Cholecalciferol granule 10 mg
Other Names:
  • Cholecalciferol granule 10 mg
Drug: Treatment BC
Bazedoxifene 20 mg, Cholecalciferol granule 10 mg
Other Names:
  • Bazedoxifene 20 mg, Cholecalciferol granule 10 mg

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alvogen Korea

Investigators

  • Principal Investigator: Park, Dong-A University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

December 23, 2016

First Submitted That Met QC Criteria

December 23, 2016

First Posted (Estimate)

December 29, 2016

Study Record Updates

Last Update Posted (Estimate)

December 29, 2016

Last Update Submitted That Met QC Criteria

December 23, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK-CTR215-I-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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