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

An Open Label, Randomized, 2-sequence, 2-period, Fasting, Single Oral Dose, Crossover Study to Evaluate the Bioequivalence and Safety of 'IN-M00007' and 'IN-R00007' in Healthy Adult Volunteers

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

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: IN-R00007; Drug: IN-M00007

Detailed Description

An open label, randomized, single oral dose, crossover study

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Heeju Ahn; Phone Number: +82 31-5176-4662; Email: heeju.ahn21@inno-n.com
• Study Contact Backup: Name: Yugyeong Park; Phone Number: +82 31-5176-4661; Email: yugyeong.park@inno-n.com

Study Locations

• South Korea
  • Seoul, South Korea
    • H PLUS Yangji Hospital, Clinical Trial Center
    • Principal Investigator: Hyeonggeon Kim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

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

   • Body weight ≥ 50kg for male
   • Body weight ≥ 45kg for female
3. Subjects who do not have significant congenital or chronic diseases and without pathological symptoms or findings based on medical examinations(if necessary, EEG, ECG, chest X-ray, gastroscopy or gastrointestinal radiographic tests)
4. Determined by the investigator to be eligible for study participation based on the results of screening tests (e.g. hematology test, blood chemistry test, serology test, urinalysis, pregnancy diagnostic tests) conducted according to the IP characteristics
5. Subjects who voluntarily signed the consent form after receiving detailed explanation and understanding about purpose, details, characteristics of the IP and anticipated adverse events of the study

6. Subjects who agree to use highly effective methods of contraception(excluding hormonal methods) to preclude the possibility of pregnancy of themselves or their spouse/partner from the first IP administration until 14 days after the last administration, and who agrees not to donate sperm or ovum during this period

   • Highly effective contraceptive methods: intrauterine device(IUD), bilateral tubal ligation, a partner who has undergone vasectomy, or sexual abstinence However, periodic abstinence(calendar method, symptothermal method, post-ovulation method), withdrawal intercourse(coitus interruptus), spermicide methods, lactational amenorrhea method, and simultaneous use of female and male condoms are not considered contraceptive methods

Exclusion Criteria:

1. 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)
2. Subjects who have participated in any other clinical study or bioequivalence study and administered IP within 6 months
3. 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)
4. Subjects with a history of gastrointestinal resection that may affect drug absorption(excluding appendectomy and hernia operation)

5. Subjects meeting following conditions within 1 month prior to the start of the study(first IP administration day)

   • Alcohol consumption > 21 glasses per week for male
   • Alcohol consumption > 14 glasses per week for female

6. Subjects with the following diseases

   • Subjects with hypersensitivity to the ingredient or components of this drug
   • Subjects with active liver disease or those with persistently elevated serum aminotransferase levels of unknown cause
   • Subjects with muscular disorders
   • Subjects receiving concomitant administration with cyclosporine
   • Subjects with severe renal impairment or kidney dysfunction
   • Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
7. Subjects with a clinically significant history of mental illness
8. Pregnant or breastfeeding women if female
9. Subjects who are judged ineligible for the clinical study by the investigator due to reasons other than the above inclusion/exclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence A; R → T R: IN-R00007, T: IN-M00007	Drug: IN-R00007; Single dose; Drug: IN-M00007; Single dose
Experimental: Sequence B; T → R R: IN-R00007, T: IN-M00007	Drug: IN-R00007; Single dose; Drug: IN-M00007; Single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK parameter	AUCt of Rosuvastatin	Up to 48 hours
PK parameter	Cmax of Rosuvastatin	Up to 48 hours
PK parameter	AUCt of Ezetimibe	Up to 72 hours
PK marameter	Cmax of Ezetimibe	up to 72 hours

Collaborators and Investigators

• Sponsor: HK inno.N Corporation
• Investigators: Principal Investigator: Hyeonggeon Kim, H Plus Yangji Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: December 14, 2025
• First Submitted That Met QC Criteria: December 30, 2025
• First Posted (Actual): December 31, 2025

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 30, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: IN_RVZ_104

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No