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

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03005340

Enrollment

Registered

2016-12-29

Start date

2016-12-31

Completion date

2017-06-30

Last updated

2016-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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

Interventions

DRUGTreatment B

Bazedoxifene 20 mg

DRUGTreatment C

Cholecalciferol granule 10 mg

DRUGTreatment BC

Bazedoxifene 20 mg, Cholecalciferol granule 10 mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026