A Study to Evaluate the Pharmacokinetics and Safety of IN-M00007 and IN-R00007 in Healthy Adult Volunteers

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-59
SponsorHK inno.N Corporation

About this trial

This study aims to evaluate the Pharmacokinetic (PK) characteristics and safety after a single oral dose administration of IN-M00007 and IN-R00007 in healthy adult volunteers

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy adult volunteers aged ≥ 19 and < 60 years at screening

Body mass index(BMI) in the range of 18.0 and 30.0 kg/㎡

Body weight ≥ 50kg for male

Body weight ≥ 45kg for female

Disqualifiers

Subjects who have taken drugs which can induce(e.g, Barbiturates) or inhibit drug metabolism enzyme within 30 days prior to the start of the study(first IP administration day) or have taken medications that may affect this study within 10 days prior to the start of the study(first IP administration day)

Subjects who have participated in any other clinical study or bioequivalence study and administered IP within 6 months

Subjects who have donated whole blood within 8 weeks prior to the start of the study(first IP administration day) or have donated component blood within 2 weeks prior to the start of the study(first IP administration day)

Subjects with a history of gastrointestinal resection that may affect drug absorption(excluding appendectomy and hernia operation)

Trial design

Design model

Crossover

Treatments tested in this trial

  • IN-R00007

    Drug

    Single dose

  • IN-M00007

    Drug

    Single dose

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Sequence AExperimental treatment 2 interventions
Group B: Sequence BExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

PK parameter

AUCt of Rosuvastatin

Time frame
Up to 48 hours
2

PK parameter

Cmax of Rosuvastatin

Time frame
Up to 48 hours
3

PK parameter

AUCt of Ezetimibe

Time frame
Up to 72 hours
4

PK marameter

Cmax of Ezetimibe

Time frame
up to 72 hours

Secondary outcomes

Other outcomes

Sponsors and contacts

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

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