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CompletedNCT02709187Updated Jun 8, 2016

DP-R208 Pharmacokinetic Study

A Phase 1 interventional study of DP-R208 and Candesartan cilexetil in Healthy, sponsored by Alvogen Korea. Completed. Open to male participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-08.

Sponsored by Alvogen Korea (part of Lotus Pharmaceutical Co., Ltd.) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
19 Years to 55 Years
Sex
Male
01

Study summary

An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of DP-R208 (Candesartan cilexetil 8mg/Rosuvastatin 10mg), a fixed dose combination compared with coadministration of separate constituents in healthy adult volunteers

02

Conditions studied

  • Healthy

Keywords

  • DP-R208
03

In context

Lead sponsor

Alvogen Korea is the lead sponsor of 24 studies on the registry; 1 is open to participants now.

Browse Alvogen Korea studies →All Lotus Pharmaceutical Co., Ltd. studies →

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

04

Who can participate

Ages eligible
19 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • BMI 18\~30
  • signed the informed consent form prior to the study participation

Exclusion criteria

Exclusion Criteria:

  • Clinically significant disease
  • Previously donate whole blood within 60 days or component blood within 14 days
  • Clinically significant allergic disease
  • Taken IP in other trial within 90 days
  • An impossible one who participates in clinical trial by investigator's decision including laboratory test result
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    RT group

    combination dose of Candesartan and Rosuvastatin and DP-R208 in order

    Drug: DP-R208 · Drug: Candesartan cilexetil · Drug: Rosuvastatin

  • Experimental
    TR group

    DP-R208 and combination dose of Candesartan and Rosuvastatin in order

    Drug: DP-R208 · Drug: Candesartan cilexetil · Drug: Rosuvastatin

Interventions

  • DrugDP-R208

    Investigational product is prescribed to all of randomized subjects

  • DrugCandesartan cilexetil

    Investigational product is prescribed to all of randomized subjects

  • DrugRosuvastatin

    Investigational product is prescribed to all of randomized subjects

06

What researchers measure

Primary outcomes

  1. Area under the plasma concentration versus time curve (AUC)

    Time frame: up to 48 hours post dose

  2. Peak Plasma Concentration (Cmax)

    Time frame: up to 48 hours post dose

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2016, a primary completion of May 2016 and a completion of May 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 17, 2016
First posted
Mar 15, 2016
Start
Mar 2016
Primary completionActual
May 2016
CompletionActual
May 2016
Last update
Jun 8, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02709187
Lead sponsor
Alvogen Korea
Responsible party
Sponsor
First posted
Mar 15, 2016
Start date
Mar 2016
Primary completion
May 2016
Completion
May 2016
Last update
Jun 8, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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