A Study to Evaluate Safety, Tolerability, and PD of Tegoprazan on Healthy Male Volunteers

Phase 1

Completed

• Conditions: Pharmacodynamics; Healthy Male Volunteers
• Interventions: Drug: Tegoprazan; Drug: Revaprazan

• Registration Number: NCT03378284
• Lead Sponsor: HK inno.N Corporation

Brief Summary

A randomized, open-label, active-controlled, multiple dose phase 1 clinical trial to evaluate safety, tolerability, and pharmacodynamics of tegoprazan after oral administration in healthy male volunteers

Detailed Description

* To compare the pharmacodynamics of multiple oral dose of tegoprazan versus the pharmacodynamics of multiple oral dose of comparator drug in healthy male volunteers.

* To evaluate the safety and tolerability of multiple oral dose of tegoprazan in healthy male volunteers.

Study Timeline

• Status Verified: 2017-12
• Study Start: 2017-12-10
• Study First Submitted: 2017-12-13
• Study First Submitted QC: 2017-12-18
• Study First Posted: 2017-12-19
• Primary Completion: 2017-12-23
• Study Completion: 2018-01-16
• Last Update Submitted: 2018-03-28
• Last Update Posted: 2018-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

• Healthy adult males aged ≥ 19 years and ≤ 50 years
• Body weight of ≥ 55.0 kg and ≤ 90.0 kg, with body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 27.0 kg/m2 at the time of screening

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Exclusion Criteria

• Presence or history of clinically significant diseases
• Presence or history of gastrointestinal disorder (gastric ulcer, GERD, Crohn's disease, etc.)
• Hypersensitivity to drugs containing study drug or proton pump inhibitor and other drugs (aspirin, antibiotics, etc.) or history of clinically significant hypersensitivity
• Serologic test positive
• Abnormal obstacle to insertion and maintenance of pH meter catheter
• History of drug abuse
• Excessive caffeine intake or persistent alcohol intake
• Not use of a medically acceptable method of contraception

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tegoprazan(Test drug)	Tegoprazan	Tegoprazan drug QD for 7 days
Active comparator drug	Revaprazan	Active comparator drug QD for 7 days

Primary Outcome Measures

Name	Time	Method
Gastric pH	up to 7 days	Gastric pH
Serum gastrin concentration	up to 9 days	Serum gastrin concentration

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of