A Pilot Study to Investigate Pharmacokinetic Characteristics After Co-administration of HCP0910 and HGP1011

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

A Pilot Study to Investigate Pharmacokinetic Characteristics After Co-administration of HCP0910 and HGP1011

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02441114
• Other study ID #: HM_COPD_PILOT
• Status: Not yet recruiting
• Phase: Phase 1
• First received: May 6, 2015
• Last updated: May 7, 2015
• Start date: June 2015
• Est. completion date: September 2015

Study information

• Verified date: May 2015
• Source: Seoul National University Hospital
• Contact: In-Jin Jang, PhD
• Phone: 82-2-2072-1666
• Email: ijjang[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

This pilot study was designed to evaluate the pharmacokinetic characteristics of fluticasone, salmeterol, and tiotropium after co-administration of HCP 0910 (Seretide 250 diskus) and HGP1011 (Spiriva capsule for inhalation) which are prescribed concomitantly for the patients with COPD.

Description:

Within 3 weeks prior to the first administration of study drug, volunteers who agreed the participation of this study by their written consent will undergo screening, including physical examination and clinical laboratory test etc, to evaluate whether they are eligible to participate in this study. Study drugs will be administered at about 8 A.M. in the morning of the drug administration day, followed by blood collection for evaluation of pharmacokinetics. The same schedule with increased dose will be proceeded after 14-day washout period.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

Inclusion Criteria:

• Age between 19 to 45, healthy male subjects (at screening)

• Body weight between 55kg - 90kg, BMI (Body Mass Index) between 18.0 - 27.0

• Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent

Exclusion Criteria:

• Volunteer who has past or present history of any diseases such as liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder

• Volunteer who had drug(Aspirin, antibiotics) hypersensitivity reaction

• Subject who already participated in other trials in 3 months

• Subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Chronic Disease
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• HCP0910 and HGP1011
Inhalation of HCP0910 (Seretide 250 diskus (Fluticasone Propionate 250 mcg/Salmeterol Xinafoate 72.5 mcg)) and HGP1011 (Spiriva capsule for inhalation (Micronized Tiotropium Bromide Monohydrate 22.5 mcg))

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUClast	Area under the concentration versus time curve from the time of dosing to the last measurable concentration	0, 2, 5, 10, 20, 30, 45, 60 min, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 h	No
Secondary	Tmax	Time to maximum concentration	0, 2, 5, 10, 20, 30, 45, 60 min, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 h	No
Secondary	Cmax	Maximum observed concentration	0, 2, 5, 10, 20, 30, 45, 60 min, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 h	No