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Healthy SubjectsPhase 1NCT05519514

Bio-Equivalence Study of Budesonide Prolonged-release Tablets 9 Mg In Healthy Human Adult Subjects

A Phase 1 study testing Cortiment and Budesonide in people with Healthy Subjects and Human Volunteers, run by Abbott at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A randomized, open label, single dose, balanced, two treatment, two sequence, four period, fully replicate, cross over bioequivalence study under fasting condition. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
What is being tested?
Cortiment and Budesonide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteIndia
Study dates
12 Jul 2021to 15 Nov 2021
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 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Normal healthy human adult male and non- pregnant female volunteers between 18-45 years (both ages inclusive) of age.
  • Who is given written informed consent and are willing to participate in the study.
  • Body Mass Index of 18.50 to 30.00 Kg/m2 (both inclusive).
  • No evidence of underlying disease during the pre-study screening, medical history, physical examination and laboratory investigations performed within 21 days prior to commencement of the study.
  • Pre-study screening laboratory tests are either normal or within acceptable limits or are considered by the Investigator to be of no clinical significance with respect to participation in the study.
  • Negative test results for alcohol (in breath or in urine) and urine drugs of abuse.
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  • Who is negative or non-reactive for antibodies to HIV 1 and 2, hepatitis B \& C and Rapid Plasma Reagin.
  • 12 lead ECG recording within normal or within acceptable limits or as considered by the Investigator to be of no clinical significance with respect to his/ her participation in the study.
  • Normal or not clinically significant chest X-ray (PA) taken within 06 months before the day of dosing.
  • Who will be available for the entire study period and is capable of understanding and communicating with the investigators and clinical study facility staff.
  • Female volunteers who are having negative results in urine pregnancy test during screening and negative Beta hCG-test at the time of check-in.
  • Females with child-bearing potential must agree to use an acceptable method of contraception at least 2 days prior to dosing of IP, during the study \& for 03 days following their last dose of IP.
  • Male subjects and/or Female subject's partner must agree to use condoms, vasectomy or spermicide in addition to female contraception for additional protection against conception throughout the study.

Who cannot join

  • Known history of hypersensitivity/ allergic to Budesonide or any component of the formulation and/or to any other related drug.
  • History or presence of significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease and malignancy.
  • Female volunteers who are:
  • Nursing mothers.
  • Positive result in beta hCG test.
  • Lactating women (currently breast feeding).
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  • Female subjects not confirming to using birth control measures, from the date of screening until the completion of the study. Abstinence, barrier methods (condom, diaphragm, etc.) are acceptable.
  • Using hormonal contraceptives either oral or implants.
  • History/presence of significant alcohol dependence (abuse) or drug abuse within the past 1year, current alcohol abuse (> 5 units/week, 1 unit= 10 mL or 8 g of pure alcohol) or suspected abuse.
  • Everyday smoker (who has smoked at least 100 cigarettes in her lifetime, and who now smokes every day) or consumption of tobacco products.
  • History/presence of Asthma.
  • History/presence of urticaria or other allergic type reactions after taking any medication.
  • History/presence of Clinically significant illness within 04 weeks before the start of the study.
  • History/presence of significant Hypersensitivity to heparin.
  • History of clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing) or any allergic reactions to any drugs.
  • Who is scheduled for surgery any time during study or within 03 days after study completion.
  • History of difficulty in donating blood.
  • Who has unsuitable veins for repeated vein puncture. Who is participating in any other clinical or bioequivalence study or otherwise would have donated in excess of 350 mL of blood in the last 90 days.
  • 15. Who has taken prescription medication or OTC products (including vitamins and natural products) within 14 days prior to dosing of IP in Period 1, including topical medication. 16. Who was hospitalized within 28 days prior to administration of the study medication. 17. History of difficulty in swallowing. 18. Evidence of skin lesions on forearm of signs of vein puncture on the forearm suggestive of recent donation or participation in clinical trial. 19. Who has Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg. Minor deviations (2-4 mm of Hg) at check-in may be acceptable at the discretion of the Investigator. 20. Who has Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor deviations (2-4 mm of Hg) at check-in may be acceptable at the discretion of the Investigator. 21. Who is tested positive for COVID-19 test.

Trial locations and contacts

1 site in 1 country.

India1 site

  • Study Site

    Mangalore

Other trials in India

About this study

Official title: A Randomized, Open Label, Single Dose, Balanced, Two Treatment, Two Sequence, Four Period, Fully Replicate, Cross Over Bio-Equivalence Study Of Budesonide Prolonged Release Tablets 9 Mg Of Abbott India Ltd., With Cortiment® 9 Mg (Budesonide), Prolonged Release Tablets Of Ferring Pharmaceuticals Ltd., UK in Healthy Human Adult Subjects Under Fasting Condition

A randomized, open label, single dose, balanced, two treatment, two sequence, four period, fully replicate, cross over bioequivalence study under fasting condition.

Being tested
Cortiment, Budesonide
Keywords
Bioequivalence, Budesonide prolonged release tablets 9 mg, Pharmacokinetic, fully replicate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CortimentDrug

    Budesonide 9 mg prolonged release tablets

  • BudesonideDrug

    Experimental (Budesonide 9 mg prolonged release tablets)

Study groups in NCT05519514
Study groupRoleWhat they receive
Cortiment (Budesonide 9 mg prolonged release tablet)Active comparatorNot described
Receives: Drug: Cortiment
Budesonide 9 mg prolonged release tabletExperimentalNot described
Receives: Drug: Budesonide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bioequivalence of Test Product (T) Vs Reference Product (R) Pharmacokinetic parameters: Cmax (Maximum plasma concentration)

    Cmax (Maximum plasma concentration)

    Measured: Till 72 hours post dose after each dosing

  2. Bioequivalence of Test Product (T) Vs Reference Product (R) Pharmacokinetic Parameters: AUC0-t (area under the curve)

    AUC0-t (area under the curve)

    Measured: Till 72 hours post dose after each dosing

Secondary outcomes (7)

  1. Safety and tolerability of Test Product (T) and the Reference Product (R) Serious adverse events

    Incidences of Serious Adverse events

    Measured: Till 30 days since last dosing period

  2. Safety and tolerability of Test Product (T) and the Reference Product (R) Systolic and diastolic blood pressure

    Vital Signs assessment in terms of:

    Systolic and diastolic blood pressure measured as mm of Hg.

    Measured: Till 72 hours post dose after each dosing

  3. Safety and tolerability of Test Product (T) and the Reference Product (R) Pulse rate

    Vital Signs assessment in terms of:

    Pulse rate measured as bpm.

    Measured: Till 72 hours post dose after each dosing

  4. Safety and tolerability of Test Product (T) and the Reference Product (R) Oral temperature

    Vital Signs assessment in terms of:

    Oral temperature measured as degree fahrenheit (°F).

    Measured: Till 72 hours post dose after each dosing

  5. Safety and tolerability of Test Product (T) and the Reference Product (R) Wellbeing assessment: Wellbeing assessment by questioning the subjects about their health status.

    Wellbeing assessment will be done as per the study site's applicable standard operating procedure, initially subjects wellbeing is recorded in "wellbeing form" by asking general questions like "How do you feel?", how are you feeling since last asked?.

    Further, overall subject response is then transcribed into the subject study CRF as below:

    Is overall wellbeing of the Volunteer Satisfactory? Satisfactory / Not satisfactory

    If it is not satisfactory, the same is treated as AE and is recorded in applicable AE form as per process.

    Measured: Till 72 hours post dose after each dosing

  6. Safety and tolerability of Test Product (T) and the Reference Product (R) adverse events

    Incidences of adverse events

    Measured: Till 21 days from AE occurence

  7. Safety and tolerability of Test Product (T) and the Reference Product (R) abnormal laboratory values

    No of subjects with abnormal laboratory values. Lab values for hematology, biochemistry and urine analysis

    Measured: Till 21 days from AE occurence

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2022
  2. Study start12 Jul 2021
  3. Primary completion8 Aug 2021
  4. Study completion15 Nov 2021

Resources

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
Model description
Cross Over
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05519514
Sponsor's protocol ID
BUDE1001
Other IDs
173-20
Status last verified
Aug 2022
First submitted
26 Jul 2022
Last updated
29 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cortiment and Budesonide in people with Healthy Subjects and Human Volunteers, run by Abbott at 1 site in India.

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 13 inclusion and 19 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 29 Aug 2022. 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 India. 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?

Bioequivalence of Test Product (T) Vs Reference Product (R) Pharmacokinetic parameters: Cmax (Maximum plasma concentration) (time frame: Till 72 hours post dose after each dosing). 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?

On the ClinicalTrials.gov record for NCT05519514.

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 29 Aug 2022.

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