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

Alvogen

Status and phase: Unknown; Phase 1

Conditions: Healthy

Treatments: Drug: Treatment B; Drug: Treatment C; Drug: Treatment BC

Study type: Interventional

Funder types: Industry

Identifiers

NCT03005340

AK-CTR215-I-01

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 6 patient groups

Group A

Active Comparator group

Description:

Period 1: Bazedoxifene 20 mg Period 2: Cholecalciferol granule 10 mg Period 3: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg

Treatment:

Drug: Treatment BC

Drug: Treatment C

Drug: Treatment B

Group B

Active Comparator group

Description:

Period 1: Bazedoxifene 20 mg Period 2: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 3: Cholecalciferol granule 10 mg

Treatment:

Drug: Treatment BC

Drug: Treatment C

Drug: Treatment B

Group C

Active Comparator group

Description:

Period 1: Cholecalciferol granule 10 mg Period 2: Bazedoxifene 20 mg Period 3: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg

Treatment:

Drug: Treatment BC

Drug: Treatment C

Drug: Treatment B

Group D

Active Comparator group

Description:

Period 1: Cholecalciferol granule 10 mg Period 2: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 3: Bazedoxifene 20 mg

Treatment:

Drug: Treatment BC

Drug: Treatment C

Drug: Treatment B

Group E

Active Comparator group

Description:

Period 1: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 2: Cholecalciferol granule 10 mg Period 3: Bazedoxifene 20 mg

Treatment:

Drug: Treatment BC

Drug: Treatment C

Drug: Treatment B

Group F

Active Comparator group

Description:

Period 1: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 2: Bazedoxifene 20 mg Period 3: Cholecalciferol granule 10 mg

Treatment:

Drug: Treatment BC

Drug: Treatment C

Drug: Treatment B