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DP-R208 Pharmacokinetic Study

DP-R208 Pharmacokinetic Study Phase I

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02709187
Enrollment
37
Registered
2016-03-15
Start date
2016-03-31
Completion date
2016-05-31
Last updated
2016-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

DP-R208

Brief 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

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

Sponsors

Alvogen Korea
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
19 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Area under the plasma concentration versus time curve (AUC)up to 48 hours post dose
Peak Plasma Concentration (Cmax)up to 48 hours post dose

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026