NCT05353010

A Study to Evaluate Effect of IN-A001 on Pharmacokinetics of Tacrolimus in Healthy Volunteers

Open-Label, 1-Sequence, 2-Period, Multiple Oral Dose Phase 1 Study to Evaluate Effect of IN-A001 on Pharmacokinetics of Tacrolimus in Healthy Volunteers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: HK inno.N Corporation · Industry
• Sex: All
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study aims to investigate the effect of IN-A001 50mg on the pharmacokinetics of Tacrolimus 5mg in healthy volunteers

Detailed description

This is a open-label, 1-sequence, 2-period, multiple oral dose, phase 1 study. Healthy subjects will be assigned to a group and sequentially administerd Tacrolimus and IN-A001.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Tacrolimus	Tacrolimus 5mg (1 mg \* 5 capsules)
DRUG	IN-A001(Tegoprazan)	IN-A001 50mg(Tegoprazan 50mg\* 1 tablet)
DRUG	IN-A001(Tegoprazan) + Tacrolimus	IN-A001 50mg(Tegoprazan 50mg\*1 tablet) and Tacrolimus 5mg(1mg \* 5capsules)

Timeline

• Start date: 2022-05-01
• Primary completion: 2022-07-01
• Completion: 2022-11-01
• First posted: 2022-04-29
• Last updated: 2022-04-29

Locations

1 site across 1 country: South Korea