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

NCT03005340 — Phase 1, Unknown, 24 participants, Alvogen Korea

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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

Registry	NCT03005340
Status	Unknown
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: none, treatment
Enrollment	24 (Actual)
Sponsor	Alvogen Korea (Industry)
Conditions	Healthy
Interventions	Treatment B, Treatment C, Treatment BC (Drug)
Dates	start 2016-12-01, primary completion 2017-03-01 (estimated), completion 2017-06-01 (estimated), first posted 2016-12-29, last updated 2016-12-29

-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

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+Arms and interventions

Arm	Type	Interventions	Description
Group A	Active comparator	Drug: Treatment B; Drug: Treatment C; Drug: Treatment BC	Period 1: Bazedoxifene 20 mg Period 2: Cholecalciferol granule 10 mg Period 3: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg
Group B	Active comparator	Drug: Treatment B; Drug: Treatment C; Drug: Treatment BC	Period 1: Bazedoxifene 20 mg Period 2: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 3: Cholecalciferol granule 10 mg
Group C	Active comparator	Drug: Treatment B; Drug: Treatment C; Drug: Treatment BC	Period 1: Cholecalciferol granule 10 mg Period 2: Bazedoxifene 20 mg Period 3: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg
Group D	Active comparator	Drug: Treatment B; Drug: Treatment C; Drug: Treatment BC	Period 1: Cholecalciferol granule 10 mg Period 2: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 3: Bazedoxifene 20 mg
Group E	Active comparator	Drug: Treatment B; Drug: Treatment C; Drug: Treatment BC	Period 1: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 2: Cholecalciferol granule 10 mg Period 3: Bazedoxifene 20 mg
Group F	Active comparator	Drug: Treatment B; Drug: Treatment C; Drug: Treatment BC	Period 1: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 2: Bazedoxifene 20 mg Period 3: Cholecalciferol granule 10 mg

Treatment B (Drug), also known as Bazedoxifene 20 mg: Bazedoxifene 20 mg
Treatment C (Drug), also known as Cholecalciferol granule 10 mg: Cholecalciferol granule 10 mg
Treatment BC (Drug), also known as Bazedoxifene 20 mg, Cholecalciferol granule 10 mg: Bazedoxifene 20 mg, Cholecalciferol granule 10 mg

+Outcome measures

Primary outcomes

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

Sex: Male, ages: 19 Years to 45 Years, accepts healthy volunteers

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

+Investigators

Park, Principal investigator, Dong-A University Hospital

My Notes

Public

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