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

Alvogen

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: bonviva

Study type: Interventional

Funder types: Industry

Identifiers

NCT01429675

DP-CTR206-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 105 patients

Sex: All

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 20 to 55 years of healthy volunteers

Exclusion criteria

• Hypersensitivity Reaction about Ibandronate or other drugs(aspirin, antibiotics)

Trial design

105 participants in 2 patient groups

Bonviva

Active Comparator group

Treatment:

Drug: bonviva

DP-R206

Experimental group

Treatment:

Drug: bonviva