COMPLETEDPhase 1

To Evaluate the Safety and Pharmacokinetic Interactions in Healthy Volunteers

The objective is to evaluate the safety and Pharmacokinetic Interactions after adminitration drug(Treatment A or B or A+B) in Healthy Volunteers

Sponsor

JW Pharmaceutical

Enrollment

48 participants

Sites

1 locations

Start Date

September 2023

Completion

December 2023

HealthyGroup 1: JW0104(Period 1), C2207(Period 2), JW0104 + C2207(Period 3)Group 2: JW0104 + C2207(Period 1), JW0104(Period 2), C2207(Period 3)Group 3: C2207(Period 1), JW0104 + C2207(Period 2), JW0104(Period 3)

Enrollment & Timeline

Completed

Target N

participants

Sites

locations

Duration

4 months

total trial span

Rate

pts/month needed

At 1 sites, each site needs to enroll approximately 12.0 patients/month to hit the enrollment target on schedule.

View on ClinicalTrials.gov

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Primary Outcomes

Cmax,ss

Day 1(0 hour), Day 8(0 hour), Day 9(0 hour), Day 10(0 hour) ~ Day 13(72 hours)

Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.

AUCτ,ss

Day 1(0 hour), Day 8(0 hour), Day 9(0 hour), Day 10(0 hour) ~ Day 13(72 hours)

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Fetching protocol from ClinicalTrials.gov…

COMPLETEDPhase 1

To Evaluate the Safety and Pharmacokinetic Interactions in Healthy Volunteers

The objective is to evaluate the safety and Pharmacokinetic Interactions after adminitration drug(Treatment A or B or A+B) in Healthy Volunteers

Sponsor

JW Pharmaceutical

Enrollment

48 participants

Sites

1 locations

Start Date

September 2023

Completion

December 2023

Enrollment & Timeline

Completed

Target N

participants

Sites

locations

Duration

4 months

total trial span

Rate

pts/month needed

At 1 sites, each site needs to enroll approximately 12.0 patients/month to hit the enrollment target on schedule.

View on ClinicalTrials.gov

Ask AI

Primary Outcomes

Cmax,ss

Day 1(0 hour), Day 8(0 hour), Day 9(0 hour), Day 10(0 hour) ~ Day 13(72 hours)

Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.

AUCτ,ss

Day 1(0 hour), Day 8(0 hour), Day 9(0 hour), Day 10(0 hour) ~ Day 13(72 hours)

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

To Evaluate the Safety and Pharmacokinetic Interactions in Healthy Volunteers

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

To Evaluate the Safety and Pharmacokinetic Interactions in Healthy Volunteers

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Eligibility

Trial Sites (1)