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

Phase 1UnknownNCT02561884

Daewoong Pharmaceutical Co. LTD.58 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Olostar Tab.DRUG

Co-administration of Olmetec and CrestorDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

AUC

Time frame: 0~72hr

Cmax

Time frame: 0~72hr

Data from ClinicalTrials.gov

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