Bioequivalence Study of Synflutide HFA Inhaler and Seretide Evohaler in Healthy Volunteers With Charcoal Block

NCT02466503 | Completed Phase 1 DMC

• 1 other identifier: MCPE14015M1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this pivotal study is to evaluate the relative bioavailability of Synflutide HFA 250/25 Inhaler and SeretideTM 250 EvohalerTM in healthy volunteers with charcoal block.

Conditions

Asthma; Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (2)

• Area Under Curve (AUC)

  Pre-dose and at 0.08, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours after dosing

• Maximum plasma concentration (Cmax)

  Pre-dose and at 0.08, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours after dosing

Secondary Outcomes (3)

• Time to reach Maximum plasma concentration (Tmax)

  Pre-dose and at 0.08, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours after dosing

• blood pressure [BP]

  pre-dose and 0.5, 2 and 24 hours after dosing

• pulse rate [PR]

  pre-dose and 0.5, 2 and 24 hours after dosing

Study Arms (2)

Synflutide HFA MDI, 250/25 mcg/dose

EXPERIMENTAL

Synflutide HFA MDI(Fluticasone propionate/ Salmeterol, 250/25mcg), Single dose, 4 puffs

Drug: Fluticasone propionate; Drug: Salmeterol (as xinafoate)

SeretideTM EvohalerTM, 250/25 mcg/dose

ACTIVE COMPARATOR

SeretideTM EvohalerTM (Fluticasone propionate/ Salmeterol, 250/25mcg), Single dose, 4 puffs

Drug: Fluticasone propionate; Drug: Salmeterol (as xinafoate)

Interventions

Fluticasone propionate DRUG

Inhaled corticosteroid, pMDI

Also known as: Flovent, Flixotide

SeretideTM EvohalerTM, 250/25 mcg/dose; Synflutide HFA MDI, 250/25 mcg/dose

Salmeterol (as xinafoate) DRUG

Beta-agonist, LABA, pMDI

Also known as: Serevent

SeretideTM EvohalerTM, 250/25 mcg/dose; Synflutide HFA MDI, 250/25 mcg/dose

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male and female volunteers, aged 20-65, inclusive.
• BMI that is within 18.0-30.0 kg/m², inclusive.
• Healthy or Non Clinical Significant, according to the medical history, ECG, Chest X-ray and physical examination as determined by the Principal Investigator/Sub-Investigator.
• Systolic blood pressure between 90-139 mmHg, inclusive, and diastolic blood pressure between 50-90 mmHg, inclusive, and pulse rate between 50-100 bpm, inclusive and temperature between 35.0-37.4℃.
• Clinical laboratory values within PPC's acceptable range according to PPC SOP VI-006.
• Ability to comprehend and be informed of the nature of the study, as assessed by PPC staff. Capable of giving written informed consent prior to receiving any study medication. Must be able to communicate effectively with clinic staff.
• Ability to fast for at least 14 hours and to consume standard meals.
• Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements.
• Agree not to have a tattoo or body piercing until the end of the study.
• Female subjects must fulfill at least one of the following:
• Be surgically sterile for a minimum of 6 months;
• Post-menopausal for a minimum of 1 year;
• Agree to avoid pregnancy and use medically acceptable method of contraception from at least 30 days prior to the study until 30 days after the study has ended (last study procedure).

You may not qualify if:

• Known history or presence of any clinically significant hepatic (e.g. active liver disease, hepatic impairment), renal/genitourinary (e.g. renal impairment), gastrointestinal, cardiovascular, cerebrovascular, pulmonary, endocrine (e.g. hypothyroidism), immunological, musculoskeletal (e.g. myopathy, rhabdomyolysis), neurological, psychiatric, dermatological or hematological disease or condition unless determined as not clinically significant by the Principal Investigator/Sub-Investigator.
• Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel disease), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), or other conditions known to interfere with the absorption, distribution, metabolism or excretion of the drug experienced within 7 days prior to first drug administration, as determined by the Principal Investigator/Sub-Investigator.
• Presence of any clinically significant illness within 30 days prior to first dosing, as determined by the Principal Investigator/Sub-Investigator.
• Presence of any significant physical or organ abnormality as determined by the Principal Investigator/Sub-Investigator.
• A positive test result for any of the following: HIV, Hepatitis B surface antigen, Hepatitis C, drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, tetrahydrocannabinol), breath alcohol test. Positive pregnancy test for female subjects.
• Known history or presence of:
• Alcohol abuse or dependence within one year prior to first drug administration;
• Drug abuse or dependence;
• Hypersensitivity or idiosyncratic reaction to fluticasone propionate, salmeterol xinafoate, its excipients, and/or related substances;
• Food allergies and/or presence of any dietary restrictions;
• Severe allergic reactions (e.g. anaphylactic reactions, angioedema).
• Intolerance to and/or difficulty with blood sampling through venipuncture.
• Abnormal diet patterns (for any reason) during the four weeks preceding the study, including fasting, high protein diets etc.
• Individuals who have donated, in the days prior to first drug administration:
• Less than 250 mL of blood in the previous 60 days

Sponsors & Collaborators

• Intech Biopharm Ltd.: lead

Study Sites (1)

Clinical Pharmacology Unit of Mackay Memorial Hospital Tamshui Branch

New Taipei City, Taiwan

Location

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Interventions

Fluticasone; Salmeterol Xinafoate

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• W K Chang, M.D

  Clinical Pharmacology Unit of Mackay Memorial Hospital Tamshui Branch

  PRINCIPAL INVESTIGATOR

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: June 2, 2015
• First Posted: June 9, 2015
• Study Start: August 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: June 9, 2015

Record last verified: 2015-06

Locations

TW (1)