Study to Evaluate Effects of Food or Proton Pump Inhibitor on

Clinical Trial Description

Evaluation criteria - Pharmacokinetic assessment with plasma concentrations of itraconazole and hydroxy-itraconazole - Safety assessments with adverse event monitoring including subjective/objective symptoms, physical examination, vital signs, and laboratory tests ;

Study Design

Related Conditions & MeSH terms

Achlorhydria

See also
Status	Clinical Trial	Phase
Completed	`NCT01399164` - Cobalamin Absorption From Fortified Food	N/A
Completed	`NCT00582972` - Does Omeprazole Decrease Intestinal Calcium Absorption?	Phase 4
Completed	`NCT00001240` - Evaluating Patients With Abnormal Levels of Gastric Acid	N/A
Completed	`NCT00550368` - Clinical Experiment of Helicobacter Pylori Transmission	N/A

See also

Status

Clinical Trial

Phase

Completed

NCT01399164 - Cobalamin Absorption From Fortified Food

N/A

Completed

NCT00582972 - Does Omeprazole Decrease Intestinal Calcium Absorption?

Phase 4

Completed

NCT00001240 - Evaluating Patients With Abnormal Levels of Gastric Acid

N/A

Completed

NCT00550368 - Clinical Experiment of Helicobacter Pylori Transmission

N/A

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT04942652
Study type	Interventional
Source	Seoul National University Hospital
Contact
Status	Completed
Phase	Phase 1
Start date	July 13, 2021
Completion date	August 24, 2021

Study to Evaluate Effects of Food or Proton Pump Inhibitor on the Pharmacokinetics of Itraconazole in Healthy Volunteers

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms