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To Evaluate the Safety and PK Characteristics in Healthy Volunteers-JW24107

A Randomized, Open-label, Single Dose, 2x4 Crossover Study to Evaluate the Safety and Pharmacokinetic Characteristics After Co-administration of JW0106 and C2101 and Administration of JW0107 in Healthy Volunteers Under Fasting Conditions

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06816719
Enrollment
47
Registered
2025-02-10
Start date
2024-09-02
Completion date
2024-11-12
Last updated
2025-02-10

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

Conditions

Healthy

Brief summary

The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0106 and C2101 and administration of JW0107 in healthy volunteers under fasting conditions.

Detailed description

Pharmacokinetic characteristics: Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group. Safety: All adverse events are summarized in terms of the number of subjects, expression rate, and number of expressions of adverse reactions by treatment group.

Interventions

DRUGTreatment A: JW0106 1 tablet + C2101 1 tablet

* Co-administration of 1 tablet of JW0106 and 1 tablet of C2101 * Administration orally with 150 mL of water under fasting conditions

DRUGTreatment B: JW0107 1 tablet

* Administration alone of 1 tablet of JW0107 * Administration orally with 150 mL of water under fasting conditions

Sponsors

JW Pharmaceutical
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

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

Inclusion criteria

Healthy volunteers

Exclusion criteria

Subjects does not meet the inclusion Criteria

Design outcomes

Primary

MeasureTime frameDescription
AUCtDay 1(0 hour~12 hour), Day 2(24 hour), Day 3(48 hour), Day 4(72 hour)Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.
CmaxDay 1(0 hour~12 hour), Day 2(24 hour), Day 3(48 hour), Day 4(72 hour)Describes the blood concentration statistically by pharmacokinetic blood

Countries

South Korea

Outcome results

None listed

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