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Not yet recruitingNCT07901114Updated Oct 28, 2026

A Bioequivalence and Safety Study of AJU-C719 and C719R in Healthy Adult Volunteers

A Phase 1 interventional study of Test Drug and Reference Drug in Hypertension, sponsored by AJU Pharm Co., Ltd.. Not yet recruiting at 1 site in South Korea. Open to participants aged 19 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-28.

Sponsored by AJU Pharm Co., Ltd. · Phase 1, Interventional, and Treatment

Updated Oct 28, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
19 Years to 65 Years
Sex
All
01

Study summary

To evaluate the bioequivalence and safety of "AJU-C719" and "C719R" in healthy adult subjects.

02

Conditions studied

  • Hypertension

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03

In context

Hypertension

6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.

This study's planned enrollment of 60 is below the median of 100 across 4,575 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

AJU Pharm Co., Ltd. is the lead sponsor of 21 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged 19 to less than 65 years at screening.
  • Healthy adults without medical conditions
  • 18-30 kg/m² (men ≥50 kg; women ≥45 kg)
  • Considered eligible based on screening examinations and laboratory tests
  • Willing to provide written
  • Willing to comply with the and reproductive restrictions during the specified study period

Exclusion criteria

Exclusion Criteria:

  • Use of prohibited medications or medications that may affect the study within the specified period before the first dose
  • Excessive alcohol consumption
  • Participation in another clinical trial within the previous 6 months
  • Blood donation within the specified period before the first dose
  • History of gastrointestinal surgery that may affect drug absorption
  • medical conditions or to the study drugs
  • Clinically significant psychiatric disorders
  • Pregnancy or breastfeeding
  • Any other condition considered inappropriate for study participation by the Investigator
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Sequence A

    Period 1: Reference Drug, Single dose / Period 2: Test Drug, Single dose

    Drug: Test Drug · Drug: Reference Drug

  • Experimental
    Sequence B

    Period 1: Test Drug, Single dose / Period 2: Reference Drug, Single dose

    Drug: Test Drug · Drug: Reference Drug

Interventions

  • DrugTest Drug

    AJU-C719

  • DrugReference Drug

    C719R

06

What researchers measure

Primary outcomes

  1. AUCt of AJU-C719

    Time frame: Pre-dose(0 hours) ~ 72 hours

  2. Cmax of AJU-C719

    Time frame: Pre-dose(0 hours) ~ 72 hours

Secondary outcomes

  1. AUCinf of AJU-C719

    Time frame: Pre-dose(0 hours) ~ 72 hours

  2. Tmax of AJU-C719

    Time frame: Pre-dose(0 hours) ~ 72 hours

  3. t1/2 of AJU-C719

    Time frame: Pre-dose(0 hours) ~ 72 hours

  4. AUCt/AUCinf of AJU-C719

    Time frame: Pre-dose(0 hours) ~ 72 hours

07

Study locations

1 site
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 28, 2026
Show all 1 update
  1. Oct 28, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07901114
Responsible party
Sponsor
First posted
Oct 28, 2026
Start date
Nov 2026 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Oct 28, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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