Health TrialsbyHealthPanel

A Study of Compare the Pharmacokinetic, Pharmacodynamic and Safety/Tolerability Characteristics Following Multiple Oral Administration of AD-234, AD-2341, and AD-2342 in Healthy Adults

ConditionGastritis
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-234, AD-2341, AD-2342 in healthy subjects.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy adult volunteers aged 19 to 50 years, inclusive, at the time of screening

Body weight between 50.0 kg and 90.0 kg, inclusive, and body mass index (BMI) between 18.5 kg/m² and 29.9 kg/m², inclusive, at the time of screening (BMI = weight [kg] / height [m]²)

For female participants: not pregnant, not breastfeeding, or surgically sterile (e.g., bilateral tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy)

Disqualifiers

Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration Other exclusions applied

Trial design

Design model

Crossover

Treatments tested in this trial

  • AD-234

    Drug

    AD-234 tablet administered orally

  • AD-2341

    Drug

    AD-2341 tablet administered orally

  • AD-2342

    Drug

    AD-2342 tablet administered orally

Treatment groups

30 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Arm A(Vonoprazan, Fexuprazan, Vonoprazan)Experimental treatment 3 interventions
Group B: Arm B(Vonoprazan, Vonoprazan, Fexuprazan)Experimental treatment 3 interventions
Group C: Arm C(Fexuprazan, Vonoprazan, Vonoprazan)Experimental treatment 3 interventions
Group D: Arm D(Fexuprazan, Vonoprazan, Vonoprazan)Experimental treatment 3 interventions
Group E: Arm E(Vonoprazan, Vonoprazan, Fexuprazan)Experimental treatment 3 interventions
Group F: Arm F(Vonoprazan, Fexuprazan, Vonoprazan)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Percent of Time With Gastric pH ≥4 During the 24-hour Interval After the 7th Dose

Time frame
From pre-dose (0h) on Day 7 to 24 hours post-dose on Day 7 of each treatment period (Period 1: Day 7-Day 8; Period 2: Day 28-Day 29; Period 3: Day 49-Day 50)

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: