Last updated: 12/17/2024 06:20:18
Bioequivalence study between two Albendazole 400 mg tablets in healthy adult participants under fed conditions
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: An Open Label, Balanced, Randomized, Two-Treatment, Four-Period, Two-Sequence, Single Oral Dose, Full Replicate Crossover, Bioequivalence Study of Albendazole Tablets IP 400 mg of Biddle Sawyer Limited (GSK group company) with Albendazole Tablets 400 mg of Glaxo SmithKline Consumer Healthcare, South Africa (PTY) Ltd in Healthy, Adult Participants under Fed Condition
Trial description: The goal of this study is to compare two formulations of Albendazole of the same dose in healthy adult participants. Researchers will compare the extent and rate to which the drug is absorbed.
Primary purpose:
Other
Trial design:
Cross-over
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Maximum plasma concentration (Cmax) of Albendazole
Timeframe: Up to 24 hours post dose
Area under the plasma concentration curve from time 0 to the last measured [AUC(0-t)] for Albendazole
Timeframe: Up to 24 hours post dose
Secondary outcomes:
Maximum plasma concentration (Cmax) of Albendazole sulfoxide
Timeframe: Up to 24 hours post dose
Area under the plasma concentration curve from time 0 to the last measured [AUC(0-t)] of Albendazole sulfoxide
Timeframe: Up to 24 hours post dose
Area under the plasma concentration-time curve extrapolated to infinity [AUC0-∞] of Albendazole and Albendazole sulfoxide
Timeframe: Up to 24 hours post dose
Time until Cmax is reached (Tmax) for Albendazole and Albendazole sulfoxide
Timeframe: Up to 24 hours post dose
Plasma concentration half-life (t1/2) of Albendazole and Albendazole sulfoxide
Timeframe: Up to 24 hours post dose
Lambda-z (λz) [Terminal elimination rate constant] of Albendazole and Albendazole sulfoxide
Timeframe: Up to 24 hours post dose
AUC_% Extrap_obs (observed percentage of extrapolated area under concentration) for Albendazole and Albendazole sulfoxide
Timeframe: Up to 24 hours post dose
Number of participants with adverse events (AE)
Timeframe: Up to 24 hours post dose
Absolute values of vital signs: Blood pressure [millimeters of mercury (mmHg)
Timeframe: Up to 24 hours post dose
Absolute values of vital signs: Respiratory rate [breaths per minute (bpm)
Timeframe: Up to 24 hours post dose
Absolute values of vital signs: Radial pulse [beats per minute (bpm)
Timeframe: Up to 24 hours post dose
Change from baseline in vital signs: Blood pressure [millimeters of mercury (mmHg)
Timeframe: Baseline (Day 1) and up to 24 hours post dose
Change from baseline in vital signs: Respiratory rate [breaths per minute (bpm)
Timeframe: Baseline (Day 1) and up to 24 hours post dose
Change from baseline in vital signs: Radial pulse [beats per minute (bpm)
Timeframe: Baseline (Day 1) and up to 24 hours post dose
Interventions:
Drug: Albendazole IP 400 mg
Drug: Albendazole 400 mg
Enrollment:
70
Observational study model:
Not applicable
Primary completion date:
2023-12-09
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Intestinal Diseases
Product
albendazole
Collaborators
Not applicable
Study date(s)
August 2023 to September 2023
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 45 Years
Accepts healthy volunteers
Yes
- a) Healthy, non-smoker, adult participants having body mass index (BMI) between 18.5 to 30.0 (both inclusive), calculated as weight in kilogram (kg)/ height in meter square (m2)
- b) Not having any significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12-lead electrocardiogram (ECG) and X-ray chest (postero-anterior view) recordings.
- a) Known hypersensitivity or idiosyncratic reaction to albendazole or any excipients or any related drug or any substance.
- b) History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
Inclusion and exclusion criteria
Inclusion criteria:
- a) Healthy, non-smoker, adult participants having body mass index (BMI) between 18.5 to 30.0 (both inclusive), calculated as weight in kilogram (kg)/ height in meter square (m2) b) Not having any significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12-lead electrocardiogram (ECG) and X-ray chest (postero-anterior view) recordings. c) Able to understand and adhere to the study procedures d) Voluntary written informed consent is given for study participation e) In case of female participants: Surgically sterilized at least 6 months prior to study participation;Or If of childbearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study, And Serum pregnancy test must be negative.
Exclusion criteria:
- a) Known hypersensitivity or idiosyncratic reaction to albendazole or any excipients or any related drug or any substance. b) History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system. c) Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or non-steroidal anti inflammatory drugs (NSAIDs) induced urticaria. d) History or presence of seizure or psychiatric disorders. e) Ingestion of a medication (prescribed medication & over the counter (OTC) medication, herbal remedies, cimetidine, praziquantel, dexamethasone, ritonavir, phenytoin, carbamazepine, phenobarbital) at any time in 14 days prior to dosing and any vaccine (including COVID-19 vaccine) from 14 days prior to dosing. In any such case participant selection will be at the discretion of the Principal Investigator. f) Receipt of an intervention or participation in a drug research study within a period of 90 days prior to the first dose of study intervention **. ** If intervention is received within 90 days where there is no blood loss except safety lab testing, participant can be included considering 10 half-lives duration of intervention received. g) A positive hepatitis screen including hepatitis B surface antigen and/or hepatitis C virus (HCV) antibodies. h) A positive test result for HIV antibody (1 and/or 2). i) The presence of clinically significant abnormal laboratory values during screening.
Trial location(s)
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2023-12-09
Actual study completion date
2023-12-09
Plain language summaries
Summary of results in plain language
Available language(s): English, Gujarati
Additional information about the trial
Additional information
Not applicable
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