AllergyPhase 1NCT02593500
Bioequivalence Study of Two Inhalation Formulations Containing Budesonide 200 µg
A Phase 1 study testing Budesonida Pulmictan® 200 µg and Budesonide 200 µg in people with Allergy, run by Reig Jofre Group at 1 site in South Africa.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Allergy
- What is being tested?
- Budesonida Pulmictan® 200 µg and Budesonide 200 µg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteSouth Africa
- Study dates
- Apr 2014to May 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 15Show fewer
- 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.
- OR
- 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.
Who cannot join
- 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.
Show all 29Show fewer
- 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.
- History of or current candida of mouth.
- Hypokalemia.
- Relevant history or laboratory or clinical findings indicative of acute or chronic disease, likely to influence study outcome.
- Donation or loss of blood equal to or exceeding 500 mL during the 8 weeks before the first administration of IMP.
- Diagnosis of hypotension made during the screening period.
- Diagnosis of hypertension made during the screening period or current diagnosis of hypertension.
- Resting pulse of > 100 beats per minute or < 40 beats per minute during the screening period, either supine or standing.
- Positive testing for human immunodeficiency virus (HIV), Hepatitis B and Hepatitis C.
- Positive urine screen for drugs of abuse.
- Positive urine screen for tobacco use.
- Positive pregnancy test.
- Unable to demonstrate proper inhalation techniques involved in using the inhalation devices during the screening training session.
- Immunization using a live organism vaccine within 4 weeks prior to the first dosing of IMP.
- Any specific investigational product safety concern.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Bloemfontein Early Phase Clinical Unit, PAREXEL International (South Africa)
Bloemfontein, Bloemfontein, 9301
About this study
Official title: 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
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.
Read the detailed description
The sponsor has developed a new formulation (test product) of an existing medication (reference product) which is intended for a variation in the existing marketing authorization.
The proposed study in healthy males and females is designed to establish a PK profile under fasting conditions for the orally inhaled test and reference products to evaluate bioequivalence.
This will be a single-dose, open-label, laboratory-blind, randomized, two-period crossover study with inhalation administered budesonide200 µg conductedunder fasting conditions inat least 52 healthy males and femalesat a single study center.
The study will comprise:
- Screening period, including serum cortisol levels and documented inhalation training, of maximum 21 days;
- Two treatment periods (each of which will include a profile period of 24 hours)separated by a wash-out period of 7 calendar days (minimum number of days based on half-life of the analyte) to 14 calendar days (maximum number of days based on logistical arrangements) between consecutive administrations of the IMP;
- A post-study visit within 72 hours of completion of the last treatment period of the study.
Participants will be assigned randomly to treatment sequence, prior to the first administration of IMP.
- Conditions
- Allergy
- Being tested
- Budesonida Pulmictan® 200 µg, Budesonide 200 µg
- Keywords
- Bioequivalence, budesonide,
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonida Pulmictan® 200 µgDrug
Also called Budesonide 200 µg (reference product (A)).
Budesonide 200 µgDrug
Also called Budesonide 200 µg (test product (B))
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Budesonida Pulmictan® 200 µg; Drug: Budesonide 200 µg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum observed plasma concentration (Cmax) obtained directly from the concentration-time data
Measured: 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)).
Measured: Up to 24 hours
Secondary outcomes (4)
tmax
Time to maximum observed plasma concentration (tmax).
Measured: Up to 24 hours
AUC (0-infinity)
Area under the plasma concentration versus time curve (AUC), with extrapolation to infinity (AUC(0-infinity)).
Measured: Up to 24 hours
Terminal elimination rate constant (λz)
Measured: Up to 24 hours
Apparent terminal elimination half-life (t1/2).
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2015 (estimated)
- Study startApr 2014
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reig Jofre Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02593500
- Sponsor's protocol ID
- RJ-BUD01
- Status last verified
- Apr 2014
- First submitted
- 29 Oct 2015
- Last updated
- 2 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02593500
- Acronym / sponsor ID
- RJ-BUD01
- Conditions
- Allergy
- Keywords
- Bioequivalence, budesonide,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Reig Jofre GroupIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 2 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The sponsor has developed a new formulation (test product) of an existing medication (reference product) which is intended for a variation in the existing marketing authorization.
The proposed study in healthy males and females is designed to establish a PK profile under fasting conditions for the orally inhaled test and reference products to evaluate bioequivalence.
This will be a single-dose, open-label, laboratory-blind, randomized, two-period crossover study with inhalation administered budesonide200 µg conductedunder fasting conditions inat least 52 healthy males and femalesat a single study center.
The study will comprise:
- Screening period, including serum cortisol levels and documented inhalation training, of maximum 21 days;
- Two treatment periods (each of which will include a profile period of 24 hours)separated by a wash-out period of 7 calendar days (minimum number of days based on half-life of the analyte) to 14 calendar days (maximum number of days based on logistical arrangements) between consecutive administrations of the IMP;
- A post-study visit within 72 hours of completion of the last treatment period of the study.
Participants will be assigned randomly to treatment sequence, prior to the first administration of IMP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmictan+Test (Treatment Sequence AB) | Experimental | Drug: Budesonida Pulmictan® 200 µg, Drug: Budesonide 200 µgTreatment 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. |
| Test+Pulmictan (treatment sequence BA) | Experimental | Drug: Budesonida Pulmictan® 200 µg, Drug: Budesonide 200 µgTreatment 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Budesonida Pulmictan® 200 µgAlso: Budesonide 200 µg (reference product (A)). | Drug | Pulmictan+Test (Treatment Sequence AB), Test+Pulmictan (treatment sequence BA) |
| Budesonide 200 µgAlso: Budesonide 200 µg (test product (B)) | Drug | Pulmictan+Test (Treatment Sequence AB), Test+Pulmictan (treatment sequence BA) |
Primary outcome
Cmax
Time frame: Up to 24 hours
Maximum observed plasma concentration (Cmax) obtained directly from the concentration-time data
AUC(0-t)
Time frame: Up to 24 hours
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)).
4 secondary outcomes
tmax
Time frame: Up to 24 hours
AUC (0-infinity)
Time frame: Up to 24 hours
Terminal elimination rate constant (λz)
Time frame: Up to 24 hours
Apparent terminal elimination half-life (t1/2).
Time frame: Up to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
Related trials for Allergy
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Budesonida Pulmictan® 200 µg and Budesonide 200 µg in people with Allergy, run by Reig Jofre Group at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: Up to 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2015.