NCT03005340

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Alvogen Korea · Industry
• Sex: Male
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	Treatment B	Bazedoxifene 20 mg
DRUG	Treatment C	Cholecalciferol granule 10 mg
DRUG	Treatment BC	Bazedoxifene 20 mg, Cholecalciferol granule 10 mg

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-03-01
• Completion: 2017-06-01
• First posted: 2016-12-29
• Last updated: 2016-12-29