A Clinical Trial to Evaluate the Safety and Pharmacokinetics of AJU-C52H in Healthy Volunteers
Study Details
Study Description
Brief Summary
To evaluate the safety and pharmacokinetic characteristics of AJU-C52H in healthy adults
Condition or Disease | Intervention/Treatment | Phase |
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|
Phase 1 |
Detailed Description
This study is to assess the safety and pharmacokinetic characteristics between co-administration of C52R1M with C52R2 and administration of AJU-C52H.
This is an open-label, randomized, single-dose, 2x2 crossover study in healthy subjects to assess the bioequivalence after taking the study drugs.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Sequence A Period 1: C52R1M(Valsartan/Amlodipine) and C52R2(Chlorthalidone), single dose Period 2: AJU-C52H(FDC tablet, Valsartan/Amlodipine/Chlorthalidone), single dose |
Drug: C52R1M Tab. and C52R2 Tab.
Single oral dose C52R1M(FDC, Valsartan/Amlodipine) 160/5 mg tablet and C52R2(Chlorthalidone) 25 mg tablet taken together
Other Names:
Drug: AJU-C52H
Single oral dose AJU-C52(Valsartan/Amlodipine/Chlorthalidone) 160/5/25 mg FDC tablet
Other Names:
|
Experimental: Sequence B Period 1: AJU-C52H(FDC tablet, Valsartan/Amlodipine/Chlorthalidone), single dose Period 2: C52R1M(Valsartan/Amlodipine) and C52R2(Chlorthalidone), single dose |
Drug: C52R1M Tab. and C52R2 Tab.
Single oral dose C52R1M(FDC, Valsartan/Amlodipine) 160/5 mg tablet and C52R2(Chlorthalidone) 25 mg tablet taken together
Other Names:
Drug: AJU-C52H
Single oral dose AJU-C52(Valsartan/Amlodipine/Chlorthalidone) 160/5/25 mg FDC tablet
Other Names:
|
Outcome Measures
Primary Outcome Measures
- AUCt of AJU-C52 [Pre-dose (0 hour), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours]
AUCt: Area under the concentration-time curve from time zero to time
- Cmax of AJU-C52 [Pre-dose (0 hour), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours]
Cmax: Maximum plasma concentration of the drug
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy adult volunteers aged ≥ 19-year-old
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Weight ≥ 50kg (man) or 45kg (woman), with calculated body mass index(BMI) of 18 to 30 kg/m2
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Those who are eligible for adequate blood pressure criteria during screening tests Systolic blood pressure: 90 to 139 mmHg Diastolic blood pressure: 60 to 89 mmHg
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Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings
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Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serum, urine test) and 12-lead ECG results during screening tests
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Those who agree to contraception during the participation of clinical trial
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Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial
Exclusion Criteria:
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Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug
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Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month before the first administration of clinical trial drug
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Those who donated whole blood and apheresis within 8 weeks or received transfusion within 4 weeks
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Those who has a history of gastrointestinal surgery
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Those who exceeding an alcohol and smoke consumption criteria Alcohol: Men - 21 glass/week, Women - 14 glass/week (1 glass: Soju 50 mL, Beer 250mL, Wine 30 mL) Smoke: 20 cigarettes/day
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Those who has a disease history of diabetic mellitus, nephropathy, biliary obstruction, dihydropyridine sensitivity, angioedema
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Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
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Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests
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Women who are pregnant or who may be pregnant and breastfeed
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | H+ Yangji Hospital | Seoul | Republic Of South Korea | Korea, Republic of |
Sponsors and Collaborators
- AJU Pharm Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21HT10602