Clinical trial NCT05077462: A Clinical Trial to Evaluate the Safety and Pharmacokinetics of AJU-C52H in Healthy Volunteers
Official title: An Open Label, Randomized, Single Dose, 2-sequence, 2-period, Cross-over Phase 1 Study to Evaluate the Safety and Pharmacokinetics of AJU-C52H Compared to Coadministration of C52R1M With C52R2 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hypertension
Lead sponsor: AJU Pharm Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-10-14
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and pharmacokinetic characteristics of AJU-C52H in healthy adults

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.

Eligibility criteria: Inclusion Criteria:

1. Healthy adult volunteers aged ≥ 19-year-old
2. Weight ≥ 50kg (man) or 45kg (woman), with calculated body mass index(BMI) of 18 to 30 kg/m2
3. 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
4. Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings
5. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serum, urine test) and 12-lead ECG results during screening tests
6. Those who agree to contraception during the participation of clinical trial
7. 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:

1. Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug
2. Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month before the first administration of clinical trial drug
3. Those who donated whole blood and apheresis within 8 weeks or received transfusion within 4 weeks
4. Those who has a history of gastrointestinal surgery
5. 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
6. Those who has a disease history of diabetic mellitus, nephropathy, biliary obstruction, dihydropyridine sensitivity, angioedema
7. Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
8. Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests
9. Women who are pregnant or who may be pregnant and breastfeed

Primary outcomes:
measure: AUCt of AJU-C52
timeFrame: Pre-dose (0 hour), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
measure: Cmax of AJU-C52
timeFrame: Pre-dose (0 hour), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: H+ Yangji Hospital
state: Republic Of South Korea
Study officials:
References: