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Clinical trial

A Randomized, Open-label, Crossover, Phase 1 Study to Evaluate Pharmacokinetics and Safety of HD-P023 in Comparison With Co-administration of Teneligliptin and Empagliflozin High in Healthy Volunteers

ID
Name
HD-MP-106
Description
The purpose of this study is to compare the pharmacokinetics and safety of HD-P023 and coadministration of Teneligliptin and Empagliflozin in healthy adult volunteers
Trial arms
Trial start
2024-04-01
Estimated PCD
2024-06-01
Trial end
2024-11-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
HD-P023
Single dose administration of HD-P023
Arms:
HD-P023
Teneligliptin
Single does administration of Teneligliptin and Empagliflozin High
Arms:
Co-administration of Teneligliptin and Empagliflozin High
Empagliflozin
Single does administration of Teneligliptin and Empagliflozin High
Arms:
Co-administration of Teneligliptin and Empagliflozin High
Size
40
Primary endpoint
Area under the plasma concentration versus time curve (AUCt) of Teneligliptin and Empagliflozin
72 hours
Peak Plasma Concentration (Cmax) of Teneligliptin and Empagliflozin
72 hours
Eligibility criteria
Inclusion Criteria: * Patients who are 19 years or older on screening * Signed informed consent * Healthy Volunteer * Other inclusion applies Exclusion Criteria: * Clinically relevant/significant findings as evaluated by the investigator * Other exclusion applied
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2024-04-02

1 organization

3 products

1 indication

Organization
Handok
Product
Empagliflozin
Indication
Healthy Control Participants
Product
HD-P023
Product
Teneligliptin