Compare and Evaluate the Safety and PK Data of a Single Dose Administration of 'AD-115A' or 'AD-1151'
ConditionGastric Ulcer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19+
SponsorAddpharma Inc.
About this trial
The study compare and evaluate the safety and pharmacokinetic characteristics of a single dose administration of 'AD-115A' or 'AD-1151' in healthy adults.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The Age equal to or greater than 19 in healthy volunteers at the time of screening visit
Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
Disqualifiers
Individuals who have taken drugs that induce (e.g., barbiturates) or inhibit drug-metabolizing enzymes within 30 days prior to the start of the study (first dosing day), or have taken drugs that may affect this study within 10 days prior to the start of the study (first dosing day)
Other exclusions applied
Trial design
Design model
Crossover
Treatments tested in this trial
AD-115A, AD-1151
DrugSingle-dose oral administration of AD-115A or AD-1151 (200 mg tablet), according to randomized sequence.
Treatment groups
46 Participants
are divided into 2 treatment groupsGroup A: Sequence AExperimental treatment 1 intervention
Group B: Sequence BExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximum concentration of drug in plasma (Cmax)
Cmax of AD-115A
Time frame
pre-dose to 24 hours2
Area under the plasma concentration-time curve during dosing interval (AUCt)
AUCt of AD-115A
Time frame
pre-dose to 24 hoursSponsors and contacts
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Source ClinicalTrials.gov