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A Study to Compare PK/PD Characteristics and Safety Profiles Between AD-120 and AD-120A

ConditionGastroesophageal Reflux Disease (GERD)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-50
SponsorAddpharma Inc.

About this trial

Primary endpoint of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics of AD-120 in healthy subjects.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Body weight equal to or greater than 50.0kg and equal to or less than 90.0kg and Body mass index (BMI) between 18.5 kg/m2 and 29.9 kg/m2 at the time of screening visit

The Age equal to or greater than 19 and equal to or less than 50 in healthy volunteers at the time of screening visit

Negative result from Serum Helicobacter pylori antibody at the time of screening visit

Disqualifiers

Patients with trouble performing pH monitor catheter

Trial design

Design model

Crossover

Treatments tested in this trial

  • AD-120A

    Drug

    Administered before the breakfast during 7 days, Oral, Tablet

  • AD-120

    Drug

    Administered before the breakfast during 7 days, Oral, Tablet

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Arm-AExperimental treatment 2 interventions
Group B: Arm-BExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Area under the plasma concentration-time curve over a dosing interval at steady state (AUCτ,ss)

AUCτ,ss after 7days repeated administration of Omeprazole

Time frame
AUCτ,ss: pre-dose to 24 hours of 1st administration versus pre-dose to 24 hours of repeated administration (7days)
2

The time of peak concentration after single dose

Tmax after 1days administration of Omeprazole

Time frame
Tmax: from pre-dose to 24 hours of 1st administration
3

Percent decrease from baseline in integrated gastric acidity measured by 24h pH monitoring

Percent decrease from baseline in integrated gastric acidity measured by 24h pH monitoring for 24-hour interval after 7th dose

Time frame
24 hours before 1st administration to 24 hours after repeated administration (7days)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Addpharma Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: