Phase 1
Completed N=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
Infections, Bacterial
Source: ClinicalTrials.gov NCT03408392 ↗
Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcomePrimary: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC [0-t]) for Cefixime — 20000; 19000 Hour*nanogram per milliliter
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC [0-t]) for Cefixime |
20000; 19000 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) Within a Participant Across All Treatments of Cefixime |
2670; 2640 | — |
| SECONDARY Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to (AUC [0-infinity]) Across All Treatments for Cefixime |
20700; 19700 | — |
| SECONDARY Time of Occurrence of Cmax (Tmax) for Cefixime |
4.005; 4.005 | — |
| SECONDARY Percentage of AUC(0-infinity) Obtained by Extrapolation (%AUCex) for Cefixime |
3.24; 3.32 | — |
| SECONDARY Terminal Phase Half-life (T1/2) for Cefixime |
3.18; 3.13 | — |
| SECONDARY Number of Participants With Non-serious Adverse Events (AE) and Serious Adverse Events (SAE) |
0; 0; 0; 0 | — |
| SECONDARY Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), and Aspartate Aminotransferase (AST) at Indicated Time-points |
16.6; 15.6; 13.6; 14.0; 16.4; 16.7 | — |
| SECONDARY Blood Urea Nitrogen (BUN) at Indicated Time-points |
10.354; 10.300; 12.945; 12.258; 10.841; 11.844 | — |
| SECONDARY Calcium, Glucose, Potassium and Sodium at Indicated Time-points |
2.393; 2.399; 2.308; 2.304; 2.364; 2.376 | — |
| SECONDARY Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points |
82.4; 83.4; 79.9; 85.9; 81.1; 78.5 | — |
| SECONDARY Total Protein at Indicated Time-points |
74.34; 74.77; 67.90; 67.97; 73.76; 72.57 | — |
| SECONDARY Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points |
0.023; 0.022; 0.024; 0.025; 0.026; 0.029 | — |
| SECONDARY Mean Corpuscular Volume (MCV) at Indicated Time-points |
85.73; 84.86; 85.30; 84.50; 84.83; 85.97 | — |
| SECONDARY Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points |
29.58; 29.44; 29.75; 29.51; 29.40; 29.68 | — |
| SECONDARY Erythrocyte Count at Indicated Time-points |
5.104; 5.020; 4.952; 4.871; 5.006; 4.971 | — |
| SECONDARY Hematocrit at Indicated Time-points |
0.437; 0.426; 0.422; 0.411; 0.424; 0.427 | — |
| SECONDARY Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points |
34.52; 34.68; 34.88; 34.89; 34.64; 34.54 | — |
| SECONDARY Percent Reticulocytes at Indicated Time-points |
1.786; 1.700; 1.757; 1.571; 1.729; 1.886 | — |
| SECONDARY Number of Participants With Potential Clinical Importance (PCI) Abnormal Findings for Urinalysis |
0; 0 | — |
| SECONDARY Respiratory Rate at Indicated Time-points |
15.0; 15.7; 17.3; 17.0; 15.5; 14.2 | — |
| SECONDARY Pulse Rate at Indicated Time-points |
67.0; 58.1; 61.0; 55.1; 61.9; 55.6 | — |
| SECONDARY Body Temperature at Indicated Time-points |
36.19; 36.27; 36.38; 36.23; 36.48; 36.59 | — |
| SECONDARY Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points |
110.6; 110.9; 113.4; 111.3; 112.3; 112.1 | — |
Eligibility 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 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 withi
Data sourced from ClinicalTrials.gov (NCT03408392). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.