Bioequivalence Study of Two Inhalation Formulations Containing Budesonide 200 µg

NCT02593500 | Completed Phase 1

• 1 other identifier: RJ-BUD01
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

A SINGLE CENTER, SINGLE DOSE, OPEN-LABEL, RANDOMIZED, TWO PERIOD CROSSOVER STUDY TO DETERMINE THE BIOEQUIVALENCE OF TWO INHALATION FORMULATIONS CONTAINING BUDESONIDE 200 µg ADMINISTERED AS 3 PUFFS (TOTAL DOSE OF 600 µg) IN AT LEAST 52 HEALTHY MALES AND FEMALES UNDER FASTING CONDITIONS The study objective is to determine whether the inhaled test product, budesonide 200 µg (pressurized inhalation suspension) and the inhaled reference product, Budesonida Pulmictan® 200 µg (budesonide; pressurized inhalation suspension) are bioequivalent. For this purpose the PK profile of budesonide will be compared after administration of a single dose of 600 µg (3 puffs) of each of the two inhalation formulations, under fasting conditions.

Conditions

Allergy

Keywords

Bioequivalence, budesonide,

Outcome Measures

Primary Outcomes (2)

• Cmax

  Maximum observed plasma concentration (Cmax) obtained directly from the concentration-time data

  Up to 24 hours

• AUC(0-t)

  Area under the plasma concentration versus time curve (AUC), from time zero to t, where t is the time of the last quantifiable concentration (AUC(0-t)).

  Up to 24 hours

Secondary Outcomes (4)

• tmax

  Up to 24 hours

• AUC (0-infinity)

  Up to 24 hours

• Terminal elimination rate constant (λz)

  Up to 24 hours

• Apparent terminal elimination half-life (t1/2).

  Up to 24 hours

Study Arms (2)

Pulmictan+Test (Treatment Sequence AB)

EXPERIMENTAL

Treatment period 1: Budesonide 200 µg (Budesonida Pulmictan® 200 µg: reference product (A)). Pressurized inhalation suspension. Single dose of 600 µg (3 puffs)per treatment period under fasting conditions. Treatment period 2: Budesonide 200 µg (test product (B)). Pressurized inhalation suspension. Single dose of 600 µg (3 puffs) per treatment period under fasting conditions.

Drug: Budesonida Pulmictan® 200 µg; Drug: Budesonide 200 µg

Test+Pulmictan (treatment sequence BA)

EXPERIMENTAL

Treatment period 1: Budesonide 200 µg (test product (B)). Pressurized inhalation suspension. Single dose of 600 µg (3 puffs) under fasting conditions. Treatment period 2: Budesonide 200 µg (Budesonida Pulmictan® 200 µg: reference product (A)). Pressurized inhalation suspension. Single dose of 600 µg (3 puffs) under fasting conditions.

Drug: Budesonida Pulmictan® 200 µg; Drug: Budesonide 200 µg

Interventions

Budesonida Pulmictan® 200 µg DRUG

Also known as: Budesonide 200 µg (reference product (A)).

Pulmictan+Test (Treatment Sequence AB); Test+Pulmictan (treatment sequence BA)

Budesonide 200 µg DRUG

Also known as: Budesonide 200 µg (test product (B))

Pulmictan+Test (Treatment Sequence AB); Test+Pulmictan (treatment sequence BA)

Eligibility Criteria

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

You may qualify if:

• Healthy males and females, 18 years and older (inclusive).
• Body Mass Index (BMI) between 18.5 and 30 kg/m2 (inclusive).
• Body mass not less than 50 kg.
• Medical history,vital signs, physical examination, standard 12-lead electrocardiogram (ECG) and laboratory investigationsmust be clinically acceptable or within laboratory reference ranges for the relevant laboratory tests, unless theinvestigator considers the deviation to be irrelevant for the purpose of the study.
• Non-smokers or past-smokers who stopped at least 3 months before entering the study.
• Serum cortisol value ≥ 275 nmol/L.
• Forced expiratory volume in 1 second (FEV1) ≥ 80% of the predicted value regarding age, height, gender and ethnicity (European Community for Coal and Steel \[ECCS\]/European Respiratory Society \[ERS\]).
• Females, if:
• Not of childbearing potential, e.g., has been surgically sterilized, undergone a hysterectomy, amenorrhea for ≥ 12 months and considered post-menopausal, Note: In postmenopausal women, the value of the serum pregnancy test may be slightly increased. This test will be repeated to confirm the results. If there is no increase indicative of pregnancy, the female will be included in the study.
• Of childbearing potential, the following conditions are to be met: Negative pregnancy test If this test is positive, the participant will be excluded from the study. In the rare circumstance that a pregnancy is discovered after the participant received IMP, every attempt must be made to follow her to term.
• Not lactating Abstaining from sexual activity(if this is the usual lifestyle of the participant) or must agree to use an accepted method of contraception, and agree to continue with the same method throughout the study Examples of reliable methods of contraception include non-hormonal intrauterine deviceand barrier methods combined with an additional contraceptive method.
• In this study the concomitant use of hormonal contraceptives as well as (cytochrome P450 \[CYP\] isoenzyme 3A4 \[CYP3A4\]) inhibitors is NOT allowed within 28 days before the first dosing and throughout the study.
• Other methods, if considered by the investigator as reliable, will be accepted.
• Written consent given for participation in the study.

You may not qualify if:

• Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
• Current alcohol use \> 21 units of alcohol (1 unit of beer = 340 mL, 1 unit of wine = 200 mL and 1 spirits = 25 mL) per week for males and \> 14 units of alcohol per week for females.
• Regular exposure to substances of abuse (other than alcohol) within the past year.
• Use of any medication, prescribed or over-the-counter or herbal remedies, within 2 weeks prior to the first administration of IMP except if this will not affect the outcome of the study in the opinion of the investigator.
• In this study the concomitant use of hormonal contraceptives as well as (cytochrome P450 \[CYP\] isoenzyme 3A4 \[CYP3A4\]) inhibitors is NOT allowed within 28 days before the first dosing and throughout the study.
• Participation in another study with an experimental drug, where the last administrationof the previous IMP was within 8 weeks before the first administration of IMP in this study.
• Treatment within the previous 3 months before the first administration of IMP with any drug with a well-defined potential for adversely affecting a major organ or system.
• A major illness during the 3 months before commencement of the screening period.
• History of hypersensitivity or allergy to the IMP or its excipients or any related medication.
• Hypersensitivity to lactose, galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption.
• History of bronchial asthma or any other bronchospastic disease.
• History of epilepsy.
• History of porphyria.
• Current cataracts present.
• Glaucoma.

Sponsors & Collaborators

• Reig Jofre Group: lead

Study Sites (1)

Bloemfontein Early Phase Clinical Unit, PAREXEL International (South Africa)

Bloemfontein, Bloemfontein, 9301, South Africa

Location

MeSH Terms

Conditions

Hypersensitivity

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

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: October 29, 2015
• First Posted: November 2, 2015
• Study Start: April 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: November 2, 2015

Record last verified: 2014-04

Locations

ZA (1)