Phase I Clinical Trial for Comparison of Pharmacokinetic Characteristics of Vorico Injection 200mg(Voriconazole) and Vfend® IV 200mg for Single Dose Crossover Intravenous Infusion in Healthy Volunteers

NCT02631954 | Completed Phase 1 Results

• 1 other identifier: 151HPS14014
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Phase I Clinical Trial for Comparison of Pharmacokinetic Characteristics of Vorico Injection 200mg(Voriconazole) and Vfend® IV 200mg for Single Dose Crossover Intravenous Infusion in Healthy Volunteers

Conditions

Aspergillus Infections; Candida Infections; Fungal Infections

Outcome Measures

Primary Outcomes (2)

• Cmax of Voriconazole

  The blood sampleing coleected from the subjects was analyzed and result was obtained.

  0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs

• AUCt of Voriconazole

  The blood sampleing coleected from the subjects was analyzed and result was obtained.

  0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs

Secondary Outcomes (5)

• Tmax of Voriconazole

  0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs

• AUCinf of Voriconazole

  0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs

• AUCt/AUCinf

  0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs

• Kel (Elemination Rate Constant)

  0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs

• t1/2

  0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs

Study Arms (2)

TR Group

EXPERIMENTAL

Test drug: Vorico Injection 200mg(Voriconazole) Wash out: 7 days Reference drug: Vfend® IV 200mg

Drug: Vorico Injection 200mg(Voriconazole); Drug: Vfend®(Voriconazole) IV 200mg

RT group

EXPERIMENTAL

Reference drug: Vfend® IV 200mg Wash out: 7 days Test drug: Vorico Injection 200mg(Voriconazole)

Drug: Vorico Injection 200mg(Voriconazole); Drug: Vfend®(Voriconazole) IV 200mg

Interventions

Vorico Injection 200mg(Voriconazole) DRUG

Vorico Injection 200mg(Voriconazole) to administered intravenously once

RT group; TR Group

Vfend®(Voriconazole) IV 200mg DRUG

Vfend®(Voriconazole) IV 200mg to administered intravenously once

RT group; TR Group

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A healthy person whose age is in between 19 to 55 during the screening tests
• Whose weight is more than 55 kg, BMI is over 18.5 and under 30.0 during the screening test. (BMI (kg/m2) = weight (kg) / {height (m)}2)
• Who is completely informed and understand about this clinical trial, voluntarily participating it, and signed to follow the given instructions
• Who is proven to fit into the clinical trial following by physical examination, ECG (electrocardiogram), clinical laboratory test, medical examination
• Who agreed to do birth control during testing
• A male who did not have vasectomy has to follow the clinically proven contraceptive methods\* listed under, and who agreed not to donate sperm during the test
• \* Clinically proven contraceptive method: intrauterine device (ex. Lippes Loop, Minera), chemical contraceptive (spermicides) for use with physical contraceptive method (males or females), contraceptive implants (ex. Implanon), tubal ligation or laparoscopy (common methods of tubal ligation)
• A woman of childbearing age who agreed on constant use of a medically disproven Dual Protection method\*\* and spermicides except hormonal contraceptive, and who also agreed not to breastfeed.
• A Dual Protection method: use of condoms, the Intrauterine Contraceptive Device, the diaphragm, the cervical cap, in the case where a sexual partner had vasectomy over 3 months ago (from the date of initial screening) or a sexual partner had been medically diagnosed sterile.

You may not qualify if:

• A person who has a history of clinically significant cardiovascular, respiratory, liver, kidney, endocrine system, immune system, urinary system diseases, blood-tumor diseases, mental illness.
• Who has a history of hypersensitivity reactions to antifungal drugs including voriconazole or similar series or other excipient ingredients (aspirin, antibiotics, etc.)
• Who has genetics issues on galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption
• Who has a history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (other than simple appendectomy and herniotomy)
• A person whose electrocardiogram value includes QTc \> 440 msec, PR \< 110 msec or PR \> 200 msec, QRS \< 60 msec or QRS \> 110 msec after screening, or who show clinically significant opinion.
• Who falls under the following results
• AST, ALT are exceeded over 1.5x the upper limit of the normal range
• Total bilirubin is exceeded over 1.5x the upper limit of the normal range
• Who shows the vital sign values of more than 140 mmHg or less than 90 mmHg in systolic pressure or more than 100 mmHg or less than 60 mmHg in diastolic blood pressure
• Who has history of drug abuses or shows a positive result in the urinary drug screen
• Who took any prescribed drugs, medicinal plants within the 2 weeks before the first day of dosing or takes any over-the-counter drugs or vitamin supplements within 1 week (but, if other conditions are met, they can still participate in the clinical test through the researcher's judgment)
• Who took other investigational drugs or bioequivalence drugs within 3 months before the first day of dosing
• Who participated in whole blood donation within 2 months before the first of dosing, or platelet donations within 1 months. Who received blood a month before the first day of dosing
• Who constantly drinks alcohol (over 21 units/week, 1 unit = 10 g of pure alcohol) or cannot stop drinking alcohol during the clinical test.
• Who smokes more than 10 cigarettes per day, or who cannot quit smoking when hospitalized

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Inha University Hospital

Incheon, 22332, South Korea

Location

Related Publications (1)

• Cho SH, Kim CW, Nam MS. Pharmacokinetics and Safety of Two Voriconazole Formulations after Intravenous Infusion in Healthy Korean Volunteers. Infect Chemother. 2020 Jun;52(2):204-211. doi: 10.3947/ic.2020.52.2.204. Epub 2020 May 29.

  PMID: 32468741 DERIVED

MeSH Terms

Conditions

Aspergillosis; Candidiasis; Mycoses

Interventions

Voriconazole

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Sang-Heon Cho, Ph.D.
• Organization: INHA UNIVERSITY HOSPITAL

shcho123@inha.ac.kr

82-32-890-1122

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2015
• First Posted: December 16, 2015
• Study Start: September 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: March 18, 2020
• Results First Posted: March 18, 2020

Record last verified: 2016-01

Locations

KR (1)