Last updated: 07/17/2024 17:28:28
Bioequivalence study between SKF101804 cefixime 200 milligram (mg)/5 milliliter (mL) suspension versus cefixime 200 mg/5 mL suspension reference product in healthy adult subjects under fasting conditions
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: An open-label, randomised, single-dose, two-period cross-over study to evaluate bioequivalence of SKF101804 Cefixime 200 mg/5 mL suspension versus Cefixime 200 mg/5 mL suspension reference product in healthy adult participants under fasting conditions
Trial description: This study is open-label, randomized two-way cross-over study to determine if cefixime 200 mg/5 mL powder for suspension (test formulation: SKF101804) is bioequivalent to cefixime 200 mg/5 mL suspension reference formulation. Study will be conducted in 28 healthy adult subjects under fasting conditions. There will be two treatment periods and each subject will participate in both periods. The washout period between both treatment periods will be 7-14 days. Subjects will be randomized to either of treatment sequences of reference followed by test or test followed by reference to receive a single dose of test or reference formulation on Day 1 in each treatment period. The study will last for 5 to 7 weeks.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Area under plasma concentration-time curve (AUC) from zero hours to last measurable concentration (AUC[0-t]) for cefixime
Timeframe: Pre-dose, 0.5, 1.0, 1.5, 2, 2.5, 3, 3.5, 4, 4.5,5, 6, 7, 8, 10, 12, 16, 20 and 24 hours post dose in period 1 and 2
Maximum plasma concentration (Cmax) for cefixime
Timeframe: Pre-dose, 0.5, 1.0, 1.5, 2, 2.5, 3, 3.5, 4, 4.5,5, 6, 7, 8, 10, 12, 16, 20 and 24 hours post dose in period 1 and 2
Secondary outcomes:
AUC from zero hours extrapolated to infinity (AUC [0-inf]) for cefixime
Timeframe: Pre-dose, 0.5, 1.0, 1.5, 2, 2.5, 3, 3.5, 4, 4.5,5, 6, 7, 8, 10, 12, 16, 20 and 24 hours post dose in period 1 and 2
Time of occurrence of Cmax (Tmax) for cefixime
Timeframe: Pre-dose, 0.5, 1.0, 1.5, 2, 2.5, 3, 3.5, 4, 4.5,5, 6, 7, 8, 10, 12, 16, 20 and 24 hours post dose in period 1 and 2
Percentage of AUC (0-inf) obtained by extrapolation (percentage AUCex) for cefixime
Timeframe: Pre-dose, 0.5, 1.0, 1.5, 2, 2.5, 3, 3.5, 4, 4.5,5, 6, 7, 8, 10, 12, 16, 20 and 24 hours post dose in period 1 and 2
Terminal phase half-life (T1/2) for cefixime
Timeframe: Pre-dose, 0.5, 1.0, 1.5, 2, 2.5, 3, 3.5, 4, 4.5,5, 6, 7, 8, 10, 12, 16, 20 and 24 hours post dose in period 1 and 2
Number of subjects with adverse events (AEs) and serious AEs (SAEs)
Timeframe: Up to Day 23
Number of subjects with abnormal hematology parameters
Timeframe: Up to Day 17
Number of subjects with abnormal clinical chemistry parameters
Timeframe: Up to Day 17
Number of subjects with abnormal systolic blood pressure assessment (SBP) and diastolic blood pressure (DBP)
Timeframe: Up to Day 17
Number of subjects with abnormal body temperature
Timeframe: Up to Day 17
Number of subjects with abnormal respiratory rate
Timeframe: Up to Day 17
Number of subjects with abnormal pulse rate
Timeframe: Up to Day 17
Interventions:
Drug: Test formulation A
Drug: Reference formulation B
Enrollment:
28
Observational study model:
Not applicable
Primary completion date:
2018-13-03
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Infections, Bacterial
Product
cefixime
Collaborators
Not applicable
Study date(s)
February 2018 to March 2018
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- Subject must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
- Subject must be healthy, non-smoker, as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Subject with history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data.
- Subjects with any other condition that is capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data.
Inclusion and exclusion criteria
Inclusion criteria:
- Subject must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
- Subject must be healthy, non-smoker, as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the normal reference range for the population being studied may be included at investigator discretion in consultation with the Medical Monitor if required, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Subject with a body weight 50 kilogram (kg) and body mass index (BMI) within the range 19-30 kilogram per meter square (kg/m^2) (inclusive).
- A healthy male subject must agree to use contraception during the treatment period and for at least 5 days after the last dose of study treatment and refrain from donating sperm during this period.
- A female subject is eligible to participate if she is not pregnant, not breastfeeding, not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 30 days after the last dose of study treatment.
- A subject should be capable of giving signed informed consent.
Exclusion criteria:
- Subject with history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data.
- Subjects with any other condition that is capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data.
- Subject with abnormal renal function, as determined by creatinine clearance and considered as clinically significant by the investigator will be excluded.
- Subject with abnormal blood pressure (BP) as determined by the investigator.
- Subject with lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- Subject who had breast cancer within the past 10 years.
- ALT >1.5 times upper limit of normal (ULN).
- Bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Subject with current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Subject with history of colitis
- Subject with history of cephalosporin induced hemolytic anemia.
- QT interval corrected for heart rate according to Bazett’s formula (QTcB) >450 milliseconds (msec). Subjects with a known risk of QT prolongation will be excluded.
- Past or intended use of over-the-counter or prescription medication including herbal medications, within 14 days prior to dosing unless in the opinion of the investigator and sponsor, the medication will not interfere with the study.
- Participation in the study would result in loss of blood or blood products in excess of 500 mL within 90 days.
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Current enrolment or past participation within the last 90 days before signing of consent in this or any other clinical study involving an investigational study treatment or any other type of medical research.
- Presence of Hepatitis B surface antigen (HBsAg) at screening. Positive Hepatitis C antibody test result at screening. Subjects with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C ribonucleic acid (RNA) test is obtained.
- Positive pre-study drug/alcohol screen.
- Positive human immunodeficiency virus (HIV) antibody test.
- Regular use of known drugs of abuse.
- Subjects with regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 gram (g) of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
- Subjects with urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- Subjects who are sensitive to heparin or heparin-induced thrombocytopenia.
- Subjects with known sensitivity to any drugs from the class of cephalosporin, or components thereof.
- Subjects with known sensitivity to any drugs from the class of penicillin, or components thereof.
- Subjects with known sensitivity to any of the study treatments, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
Trial location(s)
Location
GSK Investigational Site
Bloemfontein, Free State, South Africa, 9300
Status
Study Complete
Study documents
Protocol and 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
2018-13-03
Actual study completion date
2018-13-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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