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A Study to Evaluate the Safety, Pharmacokinetics of AD-118 and AD-1181 in Healthy Adult Subjects

ConditionChronic Heart Failure
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-64
SponsorAddpharma Inc.

About this trial

A Study to Evaluate the Safety and Pharmacokinetics of AD-118 and AD-1181 Under Fasted Conditions in Healthy Adult Subjects

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Body weight equal to or greater than 50kg and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit

Subjects aged 19 years or older and under 65 years at the screening visit

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-118, AD-1181

    Drug

    Single-dose oral administration of AD-118, according to randomized treatment sequence in a 2-period crossover design.

  • AD-118, AD-1181

    Drug

    Single-dose oral administration of AD-1181, according to randomized treatment sequence in a 2-period crossover design.

Treatment groups

74 Participants
are divided into 2 treatment groups
Group A: Sequence AExperimental treatment 1 intervention
Group B: Sequence BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Area under the plasma concentration-time curve during dosing interval (AUCt)

AUCt of AD-118

Time frame
[Time Frame: pre-dose (0hour) to 36hours]
2

Maximum concentration of drug in plasma (Cmax)

Cmax of AD-118

Time frame
Time Frame: pre-dose (0hour) to 36hours]

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: