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Study to Evaluate the Pharmacokinetic Characteristics and Safety of IN-C004 in Healthy Volunteers

An Open-label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics and Safety of IN-C004 in Healthy Volunteers

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04654078
Enrollment
48
Registered
2020-12-04
Start date
2021-01-18
Completion date
2021-02-15
Last updated
2021-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

To evaluate the pharmacokinetic characteristics and safety of IN-C004 in healthy volunteers

Detailed description

An Open-label, Randomized, Single-dose, Crossover Study

Interventions

DRUGK-CAB tab. with water

One time dose of K-CAB tab. taken with water

DRUGIN-C004 with water

One time dose of IN-C004 taken with water

DRUGIN-C004 without water

One time dose of IN-C004 taken without water

Sponsors

HK inno.N Corporation
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* History or evidence of clinically significant disease * History of drug/alcohol abuse * Participated in other studies and received investigational products within 6 months prior to the first study dose. * AST(GOT) or ALT(GPT) \> 2 X upper limit of normal at screening * Not able to use a medically acceptable contraceptive method throughout the study.

Design outcomes

Primary

MeasureTime frameDescription
AUCt of tegoprazanpre-dose(0 hour), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hoursArea under the plasma concentration-time curve of tegoprazan
Cmax of tegoprazanpre-dose(0 hour), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hoursMaximum Plasma Concentration at Steady State of tegoprazan
AUCt of tegoprazan metabolite M1pre-dose(0 hour), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hourArea under the plasma concentration-time curve of tegoprazan metabolite M1
Cmax of tegoprazan metabolite M1pre-dose(0 hour), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hoursMaximum Plasma Concentration at Steady State of tegoprazan metabolite M1

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026