A Single-dose, Randomized, Two-period, Two-treatment, Two-sequence, Crossover Bioequivalence Study on a Olostar Tab Versus Two Co-administered Reference Products Olmesartan Medoxomil and Rosuvastatin Calcium in Healthy Volunteers

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02561884

Enrollment

Registered

2015-09-28

Start date

2015-10-31

Completion date

2015-10-31

Last updated

2015-09-28

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

Conditions

Healthy

Brief summary

To demonstrate the bioequivalence of a Olostar Tab versus two co-administered reference IMPs Olmetec and Crestor.

Interventions

DRUGOlostar Tab.

DRUGCo-administration of Olmetec and Crestor

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* BMI ≥ 18.5 and ≤ 30.0 kg/m2. * No clinically significant findings in a 12-lead electrocardiogram (ECG) * Age 18-60 years at screening

Exclusion criteria

* History of severe allergy or allergic reactions to the IMPs or related drugs * History of serious clinical illness that can impact fate of drugs including major surgery

Design outcomes

Primary

Measure	Time frame
AUC	0~72hr
Cmax	0~72hr

Outcome results

None listed

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