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

NCT05519514 | Completed Phase 1

• 2 other identifiers: BUDE1001173-20
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Subjects; Human Volunteers; Healthy Participants; Bioequivalence

Keywords

Bioequivalence; Budesonide prolonged release tablets 9 mg; Pharmacokinetic; fully replicate

Outcome Measures

Primary Outcomes (2)

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

  Cmax (Maximum plasma concentration)

  Till 72 hours post dose after each dosing

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

  AUC0-t (area under the curve)

  Till 72 hours post dose after each dosing

Secondary Outcomes (7)

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

  Till 30 days since last dosing period

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

  Till 72 hours post dose after each dosing

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

  Till 72 hours post dose after each dosing

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

  Till 72 hours post dose after each dosing

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

  Till 72 hours post dose after each dosing

Study Arms (2)

Cortiment (Budesonide 9 mg prolonged release tablet)

ACTIVE COMPARATOR

Drug: Cortiment

Budesonide 9 mg prolonged release tablet

EXPERIMENTAL

Drug: Budesonide

Interventions

Cortiment DRUG

Budesonide 9 mg prolonged release tablets

Cortiment (Budesonide 9 mg prolonged release tablet)

Budesonide DRUG

Experimental (Budesonide 9 mg prolonged release tablets)

Budesonide 9 mg prolonged release tablet

Eligibility Criteria

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

You may qualify if:

• 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.
• Who is negative or non-reactive for antibodies to HIV 1 and 2, hepatitis B \& C and Rapid Plasma Reagin.
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Abbott: lead

Study Sites (1)

Study Site

Mangalore, India

Location

MeSH Terms

Interventions

Budesonide

Intervention Hierarchy (Ancestors)

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

Study Officials

• Dr. Shivani Acharya, MD pharmacology

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The randomization schedule was not be available to the bio-analytical operations team to keep them blinded on the treatment assignment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Cross Over

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: August 29, 2022
• Study Start: July 12, 2021
• Primary Completion: August 8, 2021
• Study Completion: November 15, 2021
• Last Updated: August 29, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)