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

NCT03005340 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2016-12-29

No results posted yet for this study

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

Conditions

  • Healthy

Interventions

DRUG

Treatment B

Bazedoxifene 20 mg

DRUG

Treatment C

Cholecalciferol granule 10 mg

DRUG

Treatment BC

Bazedoxifene 20 mg, Cholecalciferol granule 10 mg

Sponsors & Collaborators

  • Alvogen Korea

    lead INDUSTRY

Principal Investigators

  • Park · Dong-A University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2017-03-31
Completion
2017-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03005340 on ClinicalTrials.gov