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

Sponsor

Alvogen Korea (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03005340

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Treatment B Drug: Treatment C Drug: Treatment BC	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2016

Anticipated Primary Completion Date :

Mar 1, 2017

Anticipated Study Completion Date :

Jun 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Alvogen Korea

Investigators

Principal Investigator: Park, Dong-A University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alvogen Korea

ClinicalTrials.gov Identifier:

NCT03005340

Other Study ID Numbers:

AK-CTR215-I-01

First Posted:

Dec 29, 2016

Last Update Posted:

Dec 29, 2016

Last Verified:

Dec 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Cholecalciferol

Vitamin D

Bazedoxifene

Study Results

No Results Posted as of Dec 29, 2016