Clinical Study to Evaluate the Pharmacokinetics and Safety of CKD-339 in Healthy Volunteers

ConditionHypertension
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-55
SponsorChong Kun Dang Pharmaceutical

About this trial

This study is a randomized, open-label, single dose, crossover study to evaluate the pharmacokinetics and safety of CKD-339 in healthy volunteers.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy adults between the age of 19 and 55 (inclusive) at the time of screening test.

Subjects with a body mass index(BMI) between 18 and 30 kg/m2(BMI = Weight(kg)/ Height(m)2)

Male subjects weighing at least 50 kg

Female subjects weighing at least 45 kg

Disqualifiers

Subjects who have taken a drug metabolase-inducing and inhibiting drug such as barbitals within one month prior to the first dosing date or a drug that may interfere with this test within 10 days prior to the first dose of IP.

Subjects who had been administered investigational product from other clinical study or bioequivalence study within the 6 months prior to the first dose of IP.

Subjects who donated whole blood within 8 weeks, or blood components within 2 weeks prior to the first dose of IP.

Subjects who have a history of gastrointestinal resection that may affect the absorption of drugs.

Trial design

Design model

Crossover

Treatments tested in this trial

  • CKD-339

    Drug

    QD, PO

  • D311, D107

    Drug

    QD, PO

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: Sequence A(Reference-Test)Experimental treatment 2 interventions
Group B: Sequence B(Test-Reference)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

AUCt of CKD-339

Area under the plasma CKD-339 concentration-time curve from 0 to t

Time frame
From 0 to 72 hours postdose
2

Cmax of CKD-339

The maximum concentration of CKD-339 in plasma

Time frame
From 0 to 72 hours postdose

Secondary outcomes

Other outcomes

Sponsors and contacts

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