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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03005340
• Other study ID #: AK-CTR215-I-01
• Status: Enrolling by invitation
• Phase: Phase 1
• First received: December 23, 2016
• Last updated: December 23, 2016
• Start date: December 2016
• Est. completion date: June 2017

Study information

• Verified date: December 2016
• Source: Alvogen Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 24
• Est. completion date: June 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Treatment B
Bazedoxifene 20 mg
• Treatment C
Cholecalciferol granule 10 mg
• Treatment BC
Bazedoxifene 20 mg, Cholecalciferol granule 10 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alvogen Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	Peak plasma concentration(Cmax) of Bazedoxifene		0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h	No
Primary	Peak plasma concentration(Cmax) of Cholecalciferol		-24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h	No