CompletedNCT01429675Updated Nov 1, 2016

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

A Phase 1 interventional study of bonviva in Healthy, sponsored by Alvogen Korea. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-01.

Sponsored by Alvogen Korea · Phase 1 and Interventional

Phase: Phase 1
Study type: Interventional
Enrollment: 105
Allocation: Randomized
Ages: 20 Years to 55 Years
Sex: All

Study summary

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.

Read the detailed 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.

Conditions studied

Healthy

In context

Lead sponsor

Alvogen Korea is the lead sponsor of 23 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

20 to 55 years of healthy volunteers

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Phase 1
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 105 participants (actual)

Study arms

Active comparator
Bonviva
Drug: bonviva
Experimental
DP-R206
Drug: bonviva

Interventions

Drugbonviva
150mg Ibandronate once a month
Also known as: DP-R206 : DP11012, bonviva : B1184B01

What researchers measure

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

Study locations

1 site

Asan Medical Center
Seoul, Korea, Republic of

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01429675
Lead sponsor: Alvogen Korea
Responsible party: Sponsor
First posted: Sep 7, 2011
Start date: Aug 2011
Primary completion: Feb 2012
Completion: Mar 2012
Last update: Nov 1, 2016

Study contacts

Kyun seop Bae, M.D., Ph.D.

principal investigator · Asan Medical Center

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

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