A comparison of the bronchodilator and other responses of children to oral treatment with terbutaline tablet and solution: a bioequivalence study.
Terbutaline tablets and oral solution were tested in 16 subjects between the ages of seven and 15 in a double-blind acute cross-over study. Doses of terbutaline were 2.5, 3.75 or 5.0 mg depending upon the weight of each subject. Both formulations produced significant increases in pulmonary function between 15 minutes and five hours after drug administration as measured by FVC and FEV1. The mean maximal increase in FEV1 was 0.60 liters for the tablet and 0.70 liters for the solution. The mean maximal increase in FVC was 0.53 liters for the tablet and 0.67 for the solution. There were significant increases in heart rate following both tablet and solution. The mean increases were statistically significant between two and five hours after drug administration, ranging from two to nine beats/minute for the tablet and eight to 13 beats/minute for the solution. Terbutaline produced no clinically or statistically significant mean changes in systolic or diastolic blood pressure. The responses to tablet and solution did not differ significantly from each other in any parameter. Terbutaline tablet and oral solution were, therefore, bioequivalent.
D000284:Administration, Oral; D000293:Adolescent; D001786:Blood Glucose; D001993:Bronchodilator Agents; D002648:Child; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D008173:Lung Diseases, Obstructive / Q000188:drug therapy*; D008297:Male; D012996:Solutions; D013607:Tablets; D013726:Terbutaline / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D013810:Therapeutic Equivalency; D013997:Time Factors; D014797:Vital Capacity
D001786:Blood Glucose; D001993:Bronchodilator Agents; D012996:Solutions; D013607:Tablets; D013726:Terbutaline