Safety and Pharmacokinetic Characteristics of DP-R206 in Healthy Adult Volunteers

Alvogen Korea105 enrolled

Overview

The purpose of this study is compare the pharmacokinetic characteristics of DP-R206 (150mg Ibandronate / 24,000 IU Vitamin D3 complex tablet, qd) and Bonviva (150mg Ibandronate, qd) after oral administration in healthy adult volunteers.

The number of patient is eighty-four. Patients were randomly assigned either a Bonviva tablet(150mg Ibandronate, qd) first, DP-R206(150mg Ibandronate / 24,000 IU Vitamin D3 complex tablet, qd) Second or DP-R206(150mg Ibandronate / 24,000 IU Vitamin D3 complex tablet, qd) first, Bonviva tablet(150mg Ibandronate, qd) second.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

105

Conditions

Healthy

Interventions

bonvivaDRUG

150mg Ibandronate once a month

Eligibility

Sex: ALLMin age: 20 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 20 to 55 years of healthy volunteers Exclusion Criteria: * Hypersensitivity Reaction about Ibandronate or other drugs(aspirin, antibiotics)

Locations (1)

Asan Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Composite of pharmacokinetics

Cmax, AUClast

Time frame: predose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 24, 32, 48, 72, 120 hours post-dose

Secondary Outcomes

Composite of pharmacokinetics

AUCinf, tmax, t½β

Time frame: predose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 24, 32, 48, 72, 120 hours post-dose

Data from ClinicalTrials.gov

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