A Bioequivalence Pivotal Study of SYN010 HFA Inhaler and Symbicort® 160/4.5 in Healthy Volunteers Without Charcoal Block

NCT04494321 | Completed Phase 1

• 1 other identifier: MCPE15003M4
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this pivotal study is to evaluate the relative bioavailability of SYN010 HFA Inhaler and Symbicort 160/4.5μg in healthy volunteers without charcoal block.

Conditions

Asthma; COPD

Outcome Measures

Primary Outcomes (2)

• Area Under Curve (AUC)

  Pre-dose and at 0.03, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24 and 36 hours after dosing.

• Maximum plasma concentration (Cmax)

  Pre-dose and at 0.03, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24 and 36 hours after dosing.

Secondary Outcomes (4)

• Time to reach Maximum plasma concentration (Tmax)

  Pre-dose and at 0.03, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24 and 36 hours after dosing.

• Blood pressure (BP)

  Pre-dose and at 0.5, 16, 24 and 36 hours after dosing.

• Body temperature (BT)

  Pre-dose and at 0.5, 16, 24 and 36 hours after dosing.

• Pulse rate (PR)

  Pre-dose and at 0.5, 16, 24 and 36 hours after dosing.

Study Arms (3)

Reference 1 Symbicort Inhaler 160/4.5μg

ACTIVE COMPARATOR

Reference 1: Symbicort Inhaler (Budesonide/ Formoterol, 160/4.5μg), Single dose, 8 puffs

Drug: Budesonide; Drug: Formoterol

SYN010 HFA Inhaler

EXPERIMENTAL

SYN010 HFA (Budesonide/ Formoterol, 160/4.5μg), Single dose, 8 puffs

Drug: Budesonide; Drug: Formoterol

Reference 2 Symbicort Inhaler 160/4.5μg

ACTIVE COMPARATOR

Reference 2: Symbicort Inhaler (Budesonide/ Formoterol, 160/4.5μg), Single dose, 8 puffs

Drug: Budesonide; Drug: Formoterol

Interventions

Budesonide DRUG

Inhaled corticosteroid

Reference 1 Symbicort Inhaler 160/4.5μg; Reference 2 Symbicort Inhaler 160/4.5μg; SYN010 HFA Inhaler

Formoterol DRUG

Long Acting Beta Agonist (LABA)

Reference 1 Symbicort Inhaler 160/4.5μg; Reference 2 Symbicort Inhaler 160/4.5μg; SYN010 HFA Inhaler

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and female volunteers, aged 20-45, inclusive.
• BMI that is within 18.5-30.0 kg/m², inclusive. (The body weight should be over 50 kg, inclusive, respectively)
• Healthy or Non Clinical Significant, according to the medical history, Electrocardiography (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°C.
• Clinical laboratory values within reference range or Non-Clinical Significance (NCS) judged by the Principal Investigator/Sub-Investigator.
• Ability to comprehend and be informed of the nature of the study. 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 screening day until 30 days after study has ended (last study procedure). Medically acceptable methods of contraception include non-hormonal intrauterine device or double barrier method (condom with foam or vaginal spermicidal suppository, diaphragm with spermicide). Complete abstinence alone can be used as a method of contraception.

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: Human immunodeficiency virus (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 budesonide, formoterol fumarate dihydrate , 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

Budesonide; Formoterol Fumarate

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)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• Wen-Kuei 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: July 28, 2020
• First Posted: July 31, 2020
• Study Start: June 19, 2017
• Primary Completion: November 17, 2017
• Study Completion: November 17, 2017
• Last Updated: July 31, 2020

Record last verified: 2018-02

Locations

TW (1)