Study to Evaluate the Influence of Tegoprazan on the Pharmacokinetics of Proguanil in Healthy Volunteers

September 23, 2021 updated by: SeungHwan Lee, Seoul National University Hospital

A Randomized, Open-label, Three-period Crossover Clinical Trial to Evaluate the Influence of Tegoprazan on the Pharmacokinetics of Proguanil in Healthy Volunteers

The aim of this study is to evaluate the influence of tegoprazan on the pharmacokinetics of proguanil in healthy volunteers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Evaluation criteria

  • Pharmacokinetic assessment with plasma concentrations of proguanil and cycloguanil
  • Safety assessments with adverse event monitoring including subjective/objective symptoms, physical examination, vital signs, electrocardiogram, and laboratory tests

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Seoul National University Hospital, Clinical Trial Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy adult aged ≥ 19 years and ≤ 50 years at the time of screening
  • Body weight of ≥ 55.0 kg and ≤ 90.0 kg, with body mass index (BMI) of ≥ 19.0 kg/m2 and ≤ 30.0 kg/m2 at the time of screening
  • Extensive metabolizer (*1/*1) by CYP2C19 genotyping
  • A subject without any congenital or chronic disease, and has no medical examination result as pathological symptoms or signs
  • A subject who listened to sufficient explanation and fully understood this study, and voluntarily decided to participate and agreed in writing to comply with the precautions
  • A subject determined eligible for this study by investigator based physical examination, clinical laboratory tests, interview, etc.

Exclusion Criteria:

  • A subject with clinically significant hepatobiliary (severe hepatic impairment, etc.), renal (severe renal impairment, etc.), neurologic, immunologic, respiratory, gastrointestinal, endocrine, blood•oncology, cardiovascular (heart failure, Torsades de pointes, etc.), urinary, or, psychical diseases (except for simple dental past history such as tartar, impacted tooth, or wisdom tooth) or a history
  • A subject who has hypersensitivity to the investigational products, drugs containing the same class, or other drugs (penicillin and antibiotics, etc.), or a history of clinically significant hypersensitivity
  • A subject with a history of gastrointestinal disorders (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux disease, Crohn's disease, etc.) or surgery (except for simple appendectomy and herniotomy) that may affect the safety and pharmacokinetics of the investigational products
  • A subject with the following results in the screening test:
  • Blood AST (GOT), ALT (GPT): > Normal range upper × 1.5
  • Creatinine clearance calculated by MDRD equation: < 80mL/min
  • QTc interval: > 450 ms
  • Fasting serum glucose: > 126 mg/dL
  • Positive serological test (syphilis test, hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test)
  • A subject with systolic blood pressure < 90 mmHg or > 150 mmHg, or diastolic blood pressure < 50 mmHg or > 100 mmHg when vital signs are measured in sitting position after resting for at least 3 minutes
  • A subject with a history of or positive urine screening for drug abuse
  • A subject who administered any prescription drugs or herbal medicine within 2 weeks prior to the expected date of the first dose, or any over-the-counter drug (OTC drug, health functional food or vitamin within 1 week prior to the expected date of the first dose (However, can participate in the study if otherwise decided eligible by the investigator), or is expected to administer it
  • A subject who administered drugs that induce or inhibit the drug metabolizing enzymes, such as barbitals, within 1 week prior to the expected date of the first dose
  • A subject who participated in other clinical trial or bioequivalence study within 6 months prior to the expected date of the first dose
  • A subject who donated whole blood within 2 months or the component blood within 1 month prior to the expected date of the first dose, or received blood transfusion within 1 month prior to the expected date of the first dose
  • A subject with persistent alcohol intake (> 21 units/week, 1 unit = 10 g of pure alcohol), or inability to abstain from drinking from 3 days before the expected date of the first dose until the last discharge
  • A subject who is a currently smoker (But, can be eligible if he or she quitted smoking 3 months ago), or is not able to cease smoking from 3 months before the expected date of the first dose until the last discharge
  • A subject with inability to refrain from grapefruit-containing food from 3 days before the expected date of the first dose until the last discharge
  • A subject with excessive caffeine intake (> 5 units/day), or inability to refrain from caffeine or caffeine-containing food from 3 days before the expected date of the first dose until the last discharge
  • A subject with inability to use a medically acceptable double contraception or contraception throughout the study and for at least 4 weeks after the last dose, and with inability to agree to donate sperm until the period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Atovaquone/Proguanil 250/100 mg
A single oral administration of atovaquone/proguanil 250/100 mg
Drug: Atovaquone / Proguanil 250/100 mg
Atovaquone / Proguanil 250/100 mg tablet
Other Names:
  • Malarone
Experimental: Tegoprazan 50 mg + Atovaquone/Proguanil 250/100 mg
Oral administration of tegoprazan 50 mg once daily for 6 days and then co-administration of tegoprazan 50 mg and atovaquone/proguanil 250/100 mg at 7 day
Drug: Tegoprazan 50 mg
Tegoprazan 50 mg tablet
Other Names:
  • K-cab
Drug: Atovaquone / Proguanil 250/100 mg
Atovaquone / Proguanil 250/100 mg tablet
Other Names:
  • Malarone
Experimental: Esomeprazole 40 mg + Atovaquone/Proguanil 250/100 mg
Oral administration of esomeprazole 40 mg once daily for 6 days and then co-administration of esomeprazole 40 mg and atovaquone/proguanil 250/100 mg at 7 day
Drug: Atovaquone / Proguanil 250/100 mg
Atovaquone / Proguanil 250/100 mg tablet
Other Names:
  • Malarone
Drug: Esomeprazole 40 mg
Esomeprazole 40 mg tablet
Other Names:
  • Nexium
Experimental: Vonoprazan 20 mg + Atovaquone/Proguanil 250/100 mg
Oral administration of vonoprazan 20 mg once daily for 6 days and then co-administration of vonoprazan 20 mg and atovaquone/proguanil 250/100 mg at 7 day
Drug: Atovaquone / Proguanil 250/100 mg
Atovaquone / Proguanil 250/100 mg tablet
Other Names:
  • Malarone
Drug: Vonoprazan 20 mg
Vonoprazan 20 mg tablet
Other Names:
  • Takecab

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
AUClast of proguanil, cycloguanil
Time Frame: Pre-dose(0 hour) and up to 48 hours in each period
Systemic exposure of proguanil and cycloguanil
Pre-dose(0 hour) and up to 48 hours in each period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cmax of proguanil
Time Frame: Pre-dose(0 hour) and up to 48 hours in each period
Secondary pharmacokinetic parameters of proguanil
Pre-dose(0 hour) and up to 48 hours in each period
AUCinf of proguanil
Time Frame: Pre-dose(0 hour) and up to 48 hours in each period
Secondary pharmacokinetic parameters of proguanil
Pre-dose(0 hour) and up to 48 hours in each period
Tmax of proguanil
Time Frame: Pre-dose(0 hour) and up to 48 hours in each period
Secondary pharmacokinetic parameters of proguanil
Pre-dose(0 hour) and up to 48 hours in each period
t1/2 of proguanil
Time Frame: Pre-dose(0 hour) and up to 48 hours in each period
Secondary pharmacokinetic parameters of proguanil
Pre-dose(0 hour) and up to 48 hours in each period
CL/F of proguanil
Time Frame: Pre-dose(0 hour) and up to 48 hours in each period
Secondary pharmacokinetic parameters of proguanil
Pre-dose(0 hour) and up to 48 hours in each period
Vz/F of proguanil
Time Frame: Pre-dose(0 hour) and up to 48 hours in each period
Secondary pharmacokinetic parameters of proguanil
Pre-dose(0 hour) and up to 48 hours in each period
fe of proguanil
Time Frame: Pre-dose(0 hour) and up to 48 hours in each period
Secondary pharmacokinetic parameters of proguanil
Pre-dose(0 hour) and up to 48 hours in each period
CLR of proguanil
Time Frame: Pre-dose(0 hour) and up to 48 hours in each period
Secondary pharmacokinetic parameters of proguanil
Pre-dose(0 hour) and up to 48 hours in each period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: SeungHwan Lee, MD, PhD, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 25, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 8, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 3, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 27, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Tegoprazan_CYP2C19_DDI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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