Health TrialsbyHealthPanel

A Study to Evaluate the Pharmacokinetics and Food-effect of IN-M00002 Tablet in Healthy Adult Volunteers

ConditionHealthy Volunteer
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-55
SponsorHK inno.N Corporation

About this trial

This study aims to evaluate the pharmacokinetic (PK) following administration of IN-M00002 tablet and co-administration of tegoprazan and naproxen, and to evaluate food-effect of IN-M00002 tablet in healthy adult volunteers

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy adult aged ≥ 19 and ≤ 55 year-old at screening

Body mass index (BMI) ≥ 19.0 kg/m2 and ≤ 27.0 kg/m2 with a body weight ≥ 45 kg at screening

Those determined to be eligible for this study based on the findings of screening such as clinical laboratory tests (hematological test, blood chemistry test, blood coagulation test, urinalysis, test for viruses/bacteria, etc.), vital signs, and electrocardiogram (ECG) which are performed by the investigator according to the properties of medicines

Those who have fully understood this clinical trial via detailed explanation, were willing to voluntarily participate in this study, and agreed to give written informed consent prior to the screening

Disqualifiers

Medical history or evidence of clinically significant blood, renal, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological, musculoskeletal, oncological, or immune disease (except for history of simple dental treatment such as tartar, impacted teeth, and third molar teeth)

Previous history of gastrointestinal disease (esophageal disease such as esophageal achalasia or esophageal stricture, inflammatory bowel disease (Crohn's disease, ulcerative colitis)) or surgery (except for simple appendectomy, hernia surgery, tooth extraction, etc.) which may affect drug absorption

Sitting systolic blood pressure < 90 mmHg or ≥ 140 mmHg or diastolic blood pressure < 60 mmHg or ≥ 90 mmHg at screening

ALT or AST value > twice the upper limit of normal (ULN)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Tegoprazan

    Drug

    Tegoprazan 25 mg QD

  • Naproxen

    Drug

    Naproxen 500 mg BID

  • IN-M00002

    Drug

    IN-M00002 tablet QD

  • IN-M00002

    Drug

    IN-M00002 tablet BID

Treatment groups

74 Participants
are divided into 4 treatment groups
Group A: Part A: Sequence 1 (Treatment A - Treatment B)Experimental treatment 3 interventions
Group B: Part A: Sequence 2 (Treatment B - Treatment A)Experimental treatment 3 interventions
Group C: Part B: Sequence 1 (Treatment C - Treatment D)Experimental treatment 1 intervention
Group D: Part B: Sequence 2 (Treatment D - Treatment C)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

AUCt of tegoprazan

Area under the plasma concentration-time curve from the time of dosing to the time of the last measurable concentration

Time frame
Up to 48 hours
2

AUCt of naproxen

Area under the plasma concentration-time curve from the time of dosing to the time of the last measurable concentration

Time frame
Up to 72 hours
3

Cmax of tegoprazan

Maximum plasma concentration of tegoprazan

Time frame
Up to 48 hours
4

Cmax of naproxen

Maximum plasma concentration of naproxen

Time frame
Up to 72 hours

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

HK inno.N Corporation

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: