A Study to Evaluate the Pharmacokinetics and Safety Between HIP2503 and HCP1306 in Healthy Volunteers

ConditionHealthy
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-64
SponsorHanmi Pharmaceutical Company Limited

About this trial

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HIP2503 and HCP1306 in healthy volunteers.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 19~64 years in healthy volunteers

18 kg/m² ≤ BMI ≤ 30 kg/m², weight(men) ≥55kg / weight(women) ≥45kg

Agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm or eggs from the date of administration of the first investigational drug to 14 days after the administration of the last investigational drug

Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial

Disqualifiers

Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study

Subjects who judged ineligible by the investigator

Trial design

Design model

Crossover

Treatments tested in this trial

  • HIP2503

    Drug

    Take 1 orally disintegrating tablet once per period

  • HCP1306

    Drug

    Take 1 tablet once per period

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Arm 1Experimental treatment 2 interventions
Group B: Arm 2Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

AUCt

Pharmacokinetic evaluation

Time frame
0~72 hours
2

Cmax

Pharmacokinetic evaluation

Time frame
0~72 hours

Secondary outcomes

1

Ka

Pharmacokinetic evaluation

Time frame
0~72 hours
2

Concentration/Cmax_%

Pharmacokinetic evaluation

Time frame
0~72 hours
3

AUCinf

Pharmacokinetic evaluation

Time frame
0~72 hours
4

AUCt/AUCinf

Pharmacokinetic evaluation

Time frame
0~72 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: