To Evaluate the Food Effect on Pharmacokinetic Profiles and Safety in Healthy Volunteers

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-54
SponsorChong Kun Dang Pharmaceutical

About this trial

This is a randomized, open-label, single dose, crossover, phase 1 trial to evaluate the food effect on pharmacokinetic profiles and safety of CKD-383 in healthy volunteers

Eligibility criteria

Qualifiers

Healthy adults aged 19 to 54 years

BMI measurement result is 18.0 kg/m2 to 30 kg/m2

Written informed consent

Other inclusion criteria, as defined in the protocol

Disqualifiers

who has taken drug metabolism enzyme induction and inhibitory drugs, such as barbitale drugs, within 30 days prior to the start of the trial (Period

Other exclusive criteria, as defined in the protocol

Trial design

Treatments tested in this trial

  • CKD-383(Fed)
  • CKD-383(Fasted)

Treatment groups

28 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators