None listed
Conditions
Interventions
Intervention1: Amoxicillin-Clavulanic acid 625 mg tablet (500 mg Amoxicillin + 125 mg Clavulanic acid): Dose: 625 mg (500 mg Amoxicillin + 125 mg Clavulanic acid
Frequency: Single dose
Route of admini
Sponsors
Post Graduate Institute of Medical Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: 1 Signed and dated informed consent document indicating that they have been informed of all pertinent aspects of the study before any assessment is done 2 A participant who is willing and able to comply with scheduled visits, treatment plan, laboratory tests, study restrictions and other study procedures 3 A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, as determined by medical evaluation, including medical history, full physical examination, including blood pressure and pulse rate measurement, ECG or clinical laboratory tests 4 BMI of 18.5 to 30 and body weight more than 50 kg 5 Female participants of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for 7 days after the last dose of assigned treatment 6 Indian citizenship
Exclusion criteria
Exclusion criteria: 1 A participant who has participated in other studies including non medicinal studies involving investigational products within 30 days before dosing 2 A participant who is pregnant as confirmed by a positive hCG laboratory test or intending to become pregnant over the duration of the study 3 A participant who is breastfeeding 4 A participant with known or suspected intolerance or hypersensitivity to the study materials or closely related compounds or any of their stated ingredients or excipients in the products 5 A participant unwilling or unable to comply with lifestyle considerations 6 Diagnosis of long QT syndrome or QTc more than 450 msec for males and more than 470 msec for females at screening 7 A participant with evidence or history of clinically significant laboratory abnormality within the last 5 years that may increase the risk associated with study participation 8 Any surgical or medical condition which may significantly alter the pharmacokinetics of any drug substance 9 History of major gastrointestinal tract surgery 10 History of inflammatory bowel disease 11 Positive results in any of the virology tests done 12 Allergy to skin disinfecting agents, tape, or latex rubber, whenever appropriate substitutions cannot be applied or in the opinion of the Investigator opinion may pose a risk to the candidate 13 Any condition not identified in the protocol that in the opinion of the Investigator would confound the evaluation and interpretation of the study data or may put the participant at risk 14 Use of any medication within 2 weeks prior to admission to the unit or within less than 10 times the elimination half life of the respective drug or is anticipated to require any concomitant medication during that period or at any time throughout the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Cmax of amoxicillin for the test and the reference products 2 AUC0-t of amoxicillin for the test and the reference products 3 Cmax of clavulanic acid for the test and the reference products 4 AUC0-t of clavulanic acid for the test and the reference productsTimepoint: 0.00 (within 30 minutes before dosing) and at 0.5, 1, 1.25, 1.5, 2, 4 and 8 hours after dosing | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 AUC 0 to infinity of amoxicillin for the test and the reference products 2 AUC 0 to infinity of clavulanic acid for the test and the reference products 3 Tmax of amoxicillin for the test and the reference products 4 Tmax of clavulanic acid for the test and the reference products 5 Half life of amoxicillin for the test and the reference products 6 Half life of clavulanic acid for the test and the reference products 7 Number of treatment related adverse eventsTimepoint: 0.00 within 30 minutes before dosing and at 0.5, 1, 1.25, 1.5, 2, 4 and 8 hours after dosing | — |
Countries
India
Contacts
Public ContactSamir Malhotra
Post Graduate Institute of Medical Education & Research, Chandigarh
Outcome results
None listed