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

Alvogen Korea24 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Treatment BDRUG

Bazedoxifene 20 mg

Treatment CDRUG

Cholecalciferol granule 10 mg

Treatment BCDRUG

Bazedoxifene 20 mg, Cholecalciferol granule 10 mg

Eligibility

Sex: MALEMin age: 19 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

Peak plasma concentration(Cmax) of Bazedoxifene

Time frame: 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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.