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Not yet recruiting NCT07748702

Clinical Study to Evaluate the Pharmacokinetics and Safety of CKD-339 in Healthy Volunteers

Phase I Interventional Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CKD-339, D311, D107.
Who it may be relevant to
Registry conditions: Hypertension. Basic parameters: 19 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open Label, Randomized, Single Dose, Crossover, Phase I Study to Evaluate the Pharmacokinetics and the Safety of D311 and D107 Compared to CKD-339 in Healthy Adult Volunteers

Overview

This study is a randomized, open-label, single dose, crossover study to evaluate the pharmacokinetics and safety of CKD-339 in healthy volunteers.

Detailed description

To 76 healthy subjects, following treatments, are administered dosing in each period and wash-out period is 14 days.

Pharmacokinetic blood samples are collected up to 72hrs. The pharmacokinetic characteristics and safety are assessed.

Interventions

  • Drug CKD-339
    QD, PO
  • Drug D311, D107
    QD, PO

Primary outcome measures

  • AUCt of CKD-339 [Time frame: From 0 to 72 hours postdose]
  • Cmax of CKD-339 [Time frame: From 0 to 72 hours postdose]

Eligibility criteria

Inclusion criteria

  • Healthy adults between the age of 19 and 55 (inclusive) at the time of screening test.
  • Subjects with a body mass index(BMI) between 18 and 30 kg/m2(BMI = Weight(kg)/ Height(m)2)
  • Male subjects weighing at least 50 kg
  • Female subjects weighing at least 45 kg
  • Subjects who do not have clinically meaningful congenital or chronic diseases and who do not have medical examination results (such as electroencephalogram, electrocardiogram, chest and gastroscopy or gastrointestinal radiography, if necessary) during screening visits.
  • Subjects judged by investigators to be suitable for screening tests based on laboratory tests (e.g., blood tests, urine tests) and ECG, which were conducted according to the characteristics of the IP.
  • Subjects who voluntarily signed and dated the informed consent form after fully understanding its contents.
  • Subjects who had agreed to use medically appropriate contraceptive methods\* to exclude the possibility of pregnancy from the first dose of the IP to 14 days after the last dose, and not to donate sperm or ovum.
  • contraceptive methods: Combination use of intrauterine device (IUD) or system (IUS), vasectomy, tubal ligation, tubal occlusion and barrier methods of contraception (male condoms, female condoms, cervical caps, contraceptive diaphragm, sponges, etc.) or the use of combined spermicide, involves the simultaneous use of two or more barrier methods.

Exclusion criteria

  • Subjects who have taken a drug metabolase-inducing and inhibiting drug such as barbitals within one month prior to the first dosing date or a drug that may interfere with this test within 10 days prior to the first dose of IP.
  • Subjects who had been administered investigational product from other clinical study or bioequivalence study within the 6 months prior to the first dose of IP.
  • Subjects who donated whole blood within 8 weeks, or blood components within 2 weeks prior to the first dose of IP.
  • Subjects who have a history of gastrointestinal resection that may affect the absorption of drugs.
  • Subjects with a history of regular alcohol consumption meeting any of the following criteria within 1 month prior to the first dose of IP.
  • Man: average alcohol consumption > 21 cups/weeks
  • Woman: average alcohol consumption > 14 cups/weeks
  • Patients with the following conditions
  • Patients who have a history of hypersensitivity to main or component of clinical trial drugs and other dihydropyridine drugs
  • Patients on angiotensin converting enzyme (ACE) inhibitor or not more than 36 hours after discontinuation of administration
  • Patients with a history of angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor antagonists (ARB) administration
  • Patients with hereditary or idiopathic angioedema
  • Patients with severe liver failure, cirrhosis or biliary obstruction, bile congestion
  • Patients with diabetes or moderate to severe renal impairment (eGFR < 60mL/min/1.73m2) who have been co-administered with alliskyrene
  • Patients with primary aldosteronism
  • Shock patients (including cardiac shock)
  • Patients with severe aortic valve stenosis
  • Patients with unstable angina
  • Patients within one month of the onset of myocardial infarction
  • Subjects with a history of psychiatric disorders.
  • Subjects who are considered unsuitable for participation in this bioequivalence study by the Investigator (or delegated Sub-investigator) for reasons other than the inclusion and exclusion criteria listed above.
  • Female subjects who are pregnant, suspected of being pregnant, or breastfeeding.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Bumin Hospital — Seoul

Identifiers

NCT: NCT07748702 · A164_01BE2511

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗