Bioequivalence Study of Two Inhalation Formulations Containing Budesonide 200 µg

• Register: ClinicalTrials.gov
• Last refreshed on: 17 November 2015
• Main ID: NCT02593500
• Date of registration: 29/10/2015
• Prospective Registration: No
• Primary sponsor: Reig Jofre Group
• Public title: Bioequivalence Study of Two Inhalation Formulations Containing Budesonide 200 µg
• Scientific 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
• Date of first enrolment: April 2014
• Target sample size: 57
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02593500
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

South Africa

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Healthy males and females, 18 years and older (inclusive).

2. Body Mass Index (BMI) between 18.5 and 30 kg/m2 (inclusive).

3. Body mass not less than 50 kg.

4. 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.

5. Non-smokers or past-smokers who stopped at least 3 months before entering the study.

6. Serum cortisol value = 275 nmol/L.

7. 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]).

8. 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.

9. Written consent given for participation in the study.

Exclusion Criteria:

1. 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.

2. 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.

3. Regular exposure to substances of abuse (other than alcohol) within the past year.

4. 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.

5. 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.

6. 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.

7. 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.

8. A major illness during the 3 months before commencement of the screening period.

9. History of hypersensitivity or allergy to the IMP or its excipients or any related
medication.

10. Hypersensitivity to lactose, galactose intolerance, Lapp lactase deficiency or
glucose galactose malabsorption.

11. History of bronchial asthma or any other bronchospastic disease.

12. History of epilepsy.

13. History of porphyria.

14. Current cataracts present.

15. Glaucoma.

16. History of or current candida of mouth.

17. Hypokalemia.

18. Relevant history or laboratory or clinical findings indicative of acute or chronic
disease, likely to influence study outcome.

19. Donation or loss of blood equal to or exceeding 500 mL during the 8 weeks before the
first administration of IMP.

20. Diagnosis of hypotension made during the screening period.

21. Diagnosis of hypertension made during the screening period or current diagnosis of
hypertension.

22. Resting pulse of > 100 beats per minute or < 40 beats per minute during the screening
period, either supine or standing.

23. Positive testing for human immunodeficiency virus (HIV), Hepatitis B and Hepatitis C.

24. Positive urine screen for drugs of abuse.

25. Positive urine screen for tobacco use.

26. Positive pregnancy test.

27. Unable to demonstrate proper inhalation techniques involved in using the inhalation
devices during the screening training session.

28. Immunization using a live organism vaccine within 4 weeks prior to the first dosing
of IMP.

29. Any specific investigational product safety concern.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Allergy

Intervention(s)

Drug: Budesonide 200 µg

Drug: Budesonida Pulmictan® 200 µg

Primary Outcome(s)

AUC(0-t) [Time Frame: Up to 24 hours]

Cmax [Time Frame: Up to 24 hours]

Secondary Outcome(s)

Apparent terminal elimination half-life (t1/2). [Time Frame: Up to 24 hours]

tmax [Time Frame: Up to 24 hours]

Terminal elimination rate constant (?z) [Time Frame: Up to 24 hours]

AUC (0-infinity) [Time Frame: Up to 24 hours]

Secondary ID(s)

RJ-BUD01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors