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 1

• Conditions: Healthy
• Interventions: Drug: Olostar Tab.; Drug: Co-administration of Olmetec and Crestor

• Registration Number: NCT02561884
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-09
• Study First Submitted: 2015-09-24
• Study First Submitted QC: 2015-09-25
• Last Update Submitted: 2015-09-25
• Study First Posted: 2015-09-28
• Last Update Posted: 2015-09-28
• Study Start: 2015-10
• Primary Completion: 2015-10
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AB	Co-administration of Olmetec and Crestor	Olostar Tab. followed by Olmetec and Crestor
BA	Co-administration of Olmetec and Crestor	Olmetec and Crestor followed by Olostar Tab.
BA	Olostar Tab.	Olmetec and Crestor followed by Olostar Tab.
AB	Olostar Tab.	Olostar Tab. followed by Olmetec and Crestor

Primary Outcome Measures

Name	Time	Method
AUC	0~72hr
Cmax	0~72hr