Pharmacokinetics of Co-administration of Seretide 250 Diskus (HCP0910) and Spiriva Capsule for Inhalation (HGP1011)

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: Male

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 chronic obstructive pulmonary disease (COPD).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Fluticasone; Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Fluticasone-Salmeterol Drug Combination; Salmeterol Xinafoate; Tiotropium Bromide

Criteria

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