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Phase 1 Completed N=26 Randomized Treatment

Bioequivalence Study Between GR37547 500 Milligrams (mg) Tablet Versus Ciprofloxacin 500 mg Tablet Reference Product in Healthy Adult Subjects

Infections, Bacterial
Source: ClinicalTrials.gov NCT03150082 ↗
Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcomePrimary: Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC[0-t]) for Ciprofloxacin — 11600; 11300 Hour*nanogram per milliliter

Summary

This two-period cross-over study will evaluate bioequivalence of GR37547 (ciprofloxacin 500 mg) tablet versus ciprofloxacin 500 mg reference tablet in healthy adult subjects under fasting conditions. Subjects will receive Treatment A (GR37547 tablet) and Treatment B (ciprofloxacin reference tablet) in crossover manner, separated by a washout period of at least 7 days and not more than 14 days. The total duration of study for each subject will be approximately 5-7 weeks. This study will enroll approximately 26 healthy adult subjects at a single center.

Outcome Measures

OutcomeResultp-value
PRIMARY
Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC[0-t]) for Ciprofloxacin
11600; 11300
PRIMARY
Maximum Observed Plasma Concentration (Cmax) of Ciprofloxacin
3140; 2940
SECONDARY
Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) for Ciprofloxacin
12000; 11600
SECONDARY
Time of Occurrence of Cmax (Tmax) for Ciprofloxacin
1.253; 1.009 0.3499
SECONDARY
Percentage of AUC (0-infinity) Obtained by Extrapolation (Percentage AUCex) for Ciprofloxacin
2.83; 2.85
SECONDARY
Terminal Phase Half-life (t1/2) for Ciprofloxacin
5.02; 4.82
SECONDARY
Number of Participants With Serious Adverse Events (SAEs) and Non-serious AEs (Non-SAEs)
6; 6; 0; 0
SECONDARY
Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points
17.3; 18.0; 15.3; 16.4; 21.2; 16.6
SECONDARY
Blood Urea Nitrogen (BUN) at Indicated Time-points
11.322; 10.392; 10.909; 10.073; 11.444; 11.682
SECONDARY
Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points
2.354; 2.337; 2.269; 2.250; 2.335; 2.348
SECONDARY
Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points
9.39; 9.05; 8.18; 7.88; 9.29; 8.78
SECONDARY
Total Protein at Indicated Time-points
75.45; 74.58; 70.32; 68.82; 73.31; 76.51
SECONDARY
Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points
0.032; 0.022; 0.031; 0.018; 0.019; 0.033
SECONDARY
Mean Corpuscular Volume (MCV) at Indicated Time-points
82.95; 83.01; 82.88; 82.65; 83.42; 83.30
SECONDARY
Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points
29.05; 28.86; 29.13; 29.02; 28.89; 28.88
SECONDARY
Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points
35.00; 34.78; 35.12; 35.09; 34.62; 34.58
SECONDARY
Percent Reticulocytes at Indicated Time-points
2.277; 2.069; 2.085; 2.123; 2.362; 2.167
SECONDARY
Hematocrit at Indicated Time-points
0.413; 0.408; 0.399; 0.391; 0.400; 0.410
SECONDARY
Erythrocyte Count at Indicated Time-points
4.975; 4.922; 4.812; 4.733; 4.804; 4.918
SECONDARY
Number of Participants With Clinically Significant Abnormal Findings for Urinalysis
0; 0
SECONDARY
Number of Participants With Clinically Significant Abnormal Findings for Electrocardiogram (ECG) Parameters
0; 0
SECONDARY
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points
107.2; 109.8; 108.4; 106.3; 109.2; 108.8
SECONDARY
Respiratory Rate at Indicated Time-points
17.2; 16.6; 15.1; 15.2; 17.4; 16.5
SECONDARY
Pulse Rate at Indicated Time-points
63.2; 69.4; 64.2; 67.0; 65.5; 68.2
SECONDARY
Body Temperature at Indicated Time-points
36.43; 36.47; 36.68; 36.62; 36.51; 36.48

Eligibility Criteria

Inclusion Criteria

  • Subject must be between 18 and 60 years of age inclusive, at the time of signing the informed consent.
  • 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 only if the investigator 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.
  • Body weight >=50 kilogram (kg) and body mass index (BMI) within the range 19-30 kg per meter square (kg/m^2) (inclusive).
  • Healthy Male or female subjects: Male subjects: A 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; Female subjects: A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: 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.
  • The investigator is responsible for ensuring that male and female study subjects understand how to correctly use the methods of contraception.
  • Capable of giving signed informed consent.

Exclusion Criteria

  • History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neuromuscular, psychiatric, auto-immune or neurological disorders.
  • History of convulsions.
  • 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.
  • History of any malignancies or chemotherapy/radiation within the past 5 years excluding treated squamous carcinoma of the skin and adequately excised basal cell carcinoma.
  • History of kidney, heart or lung transplants.
  • History or presence of rheumatoid arthritis.
  • Presence of hypocalcaemia where the serum potassium is =7 millimoles (mmol)/liter (L).
  • Serum glucose-6-phosphate dehydrogenase 1.5x upper limit of normal (ULN).
  • Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin =9), as determined on Day -1.
  • Abnormal BP as determined by the investigator.
  • 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. For purposes of data analysis, only QTcB, will be used
  • 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.
  • Where participation in the study would result in loss of blood or blood products in excess of 500 milliliter (mL) within 90 days.
  • Exposure to more than 4 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.
  • Presence of Hepatitis B surface antigen (HBsAg) at screening or a Positive Hepatitis C antibody test result at screening.
  • Positive pre-study drug/alcohol screen.
  • Positive human immunodeficiency virus (HIV) antibody test.
  • Regular use of known drugs of abuse.
  • Sensitivity to heparin or heparin-induced thrombocytopenia.
  • Sensitivity to any of the study treatments, or c
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03150082). 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.

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