Health TrialsbyHealthPanel

Bioequivalence Study Between YHP2508C and YHR2603 in Healthy Subjects

ConditionHealthy Subjects
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-54
SponsorYuhan Corporation

About this trial

An open-label, randomized, fasting, single-dose, oral administration, 2-sequence, 4-period, replicate crossover study to evaluate bioequivalence between YHP2508C and YHR2603 in healthy subjects

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

BMI 18-30 kg/m2

Those without clinically significant congenital or chronic diseases

Disqualifiers

Those who have participated in a bioequivalence study or other clinical trials and have been administered investigational products within 6 months prior to the first administration.

Those who are judged ineligible to participate in the trial by the principal investigator.

Female volunteers who are pregnant, suspected to be pregnant or breastfeeding.

Trial design

Design model

Crossover

Treatments tested in this trial

  • YHP2508C

    Drug

    Test drug

  • YHR2603

    Drug

    Comparator drug

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: A(RTRT)Experimental treatment 2 interventions
Group B: B(TRTR)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Area under the plasma drug concentration-time curve [AUCt]

Area under the plasma drug concentration-time curve \[AUCt\] of Amlodipine, Telmisartan \& Chlorthalidone

Time frame
0-72 hours
2

Maximum plasma concentration [Cmax]

Maximum plasma concentration \[Cmax\] of Amlodipine, Telmisartan \& Chlorthalidone

Time frame
0-72 hours

Secondary outcomes

1

Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf]

Area under the plasma drug concentration-time curve from time 0 to infinity \[AUCinf\] of Amlodipine, Telmisartan \& Chlothalidone

Time frame
0-72 hours
2

Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf]

Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity \[AUCt/AUCinf\] of Amlodipine, Telmisartan \& Chlorthalidone

Time frame
0-72 hours
3

Time of peak concentration [Tmax]

Time of peak concentration \[Tmax\] of Amlodipine, Telmisartan \& Chlorthalidone

Time frame
0-72 hours
4

Terminal phase of half-life [t1/2]

Terminal phase of half-life \[t1/2\] of Amlodipine, Telmisartan \& Chlorthalidone

Time frame
0-72 hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Yuhan Corporation

Lead sponsor

Source ClinicalTrials.gov

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