Clinical trial
A Randomized, Open-label, 2x2 Crossover-design Clinical Trial to Evaluate the Safety and Pharmacokinetic/Pharmacodynamic Characteristics After Oral Administration of AD-212-A or AD-2121 in Healthy Adult Volunteers
Name
AD-212PK/PD-03
Description
Primary endpoint of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics of AD-212-A in healthy subjects.
Trial arms
Trial start
2023-09-15
Estimated PCD
2024-06-15
Trial end
2024-06-15
Status
Recruiting
Phase
Early phase I
Treatment
Lansoprazole 15 mg
AD-2121 (Lansoprazole 15 mg), Oral, Capsule
Arms:
Arm-A, Arm-B
Lansoprazole 15mg/Calcium carbonate 600mg
AD-212-A (Lansoprazole 15mg/Calcium carbonate 600mg), Oral, Tablet
Arms:
Arm-A, Arm-B
Size
24
Primary endpoint
Area under the plasma concentration-time curve over a dosing interval at steady state (AUCτ,ss)
pre-dose to 24 hours of 1st administration versus pre-dose to 24 hours of repeated administration (7days)
Percent Decrease from baseline of Integrated gastric acidity
24 hours before 1st administration to 24 hours after repeated administration (7days)
Eligibility criteria
Inclusion Criteria:
* Body weight equal to or greater than 50kg and Body mass index (BMI) between 18.5 kg/m2 and 27.0 kg/m2 at the time of screening visit
* The Age equal to or greater than 19 in healthy volunteers at the time of screening visit
* Negative result from Serum Helicobacter pylori antibody at the time of screening visit
Exclusion Criteria:
* Patients with trouble performing Gastric pH monitoring
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ESTIMATED'}}
Updated at
2024-02-01
1 organization
3 products
1 indication
Organization
AddpharmaProduct
LansoprazoleIndication
Gastroesophageal reflux