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A Study to Evaluate the Safety and Pharmacokinetics of AD-231 Compared to Coadministration of AD-231A, AD-231D and AD-231C

ConditionsDyslipidemiaHypertension
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-231 Compared to Coadministration of AD-231A, AD-231D and AD-231C

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit

The Age equal to or greater than 19 and under 65 years in healthy volunteers at the time of 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-231

    Drug

    AD-231 Oral Tablet

  • AD-231A, AD-231D and AD-231C

    Drug

    AD-231A Oral Tablet + AD-231D Oral Tablet + AD-231C Oral Tablet

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Sequence A (RT)Experimental treatment 2 interventions
Group B: Sequence B (TR)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Maximum concentration of drug in plasma (Cmax)

Cmax

Time frame
pre-dose to 72 hours
2

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

AUCt

Time frame
pre-dose to 72 hours

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: