Last updated: 11/03/2018 21:27:32
Pharmacokinetic and Pharmacodynamic Study of Intravenous Augmentin 2.2g in Thai Healthy Volunteers
GSK study ID
201294
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
Official title: Pharmacokinetic and Pharmacodynamic Study of Intravenous Augmentin 2.2g in Thai Healthy Volunteers
Trial description: This study is a randomized, open-labeled, two-treatment, two-phase, two-sequence, single dose crossover with 1-week washout phase between Phase I and Phase II dosing of intravenous AUGMENTIN 1000/200 milligram (mg) (AUGMENTIN 1.2gram[g]) and 2000/200 mg (AUGMENTIN 2.2g) in Thai healthy subjects. AUGMENTIN is widely used antibiotics and is effective over numerous of micro-organism. AUGMENTIN is a broad spectrum antibiotic covering a wide range of bacterial infections including upper and lower respiratory tract infections, skin and soft tissue infections and infection of the genitor-urinary tract. This study aims to directly investigate the pharmacokinetic properties and the in vitro bactericidal activity of intravenous AUGMENTIN 2.2 g compared to AUGMENTIN 1.2 g. Results of this study will be of benefit to the patients whose infections are susceptible to AUGMENTIN and to be treated with the 2000/200mg regimen. All subjects will be under this study protocol for at least 10 days, starting from study phase 1 visit 1 to study phase 2 visit 2. Subject will be confined to the clinical study site for 12 hours post dose of each phase.AUGMENTIN is a registered trademark of the GSK group of companies.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Area under the plasma concentration-time curve (AUC) of amoxicillin-clavulanate
Timeframe: Up to Day 10
Time to maximal plasma concentration (tmax) of amoxicillin-clavulanate
Timeframe: Up to Day 10
Elimination rate constant (Kel) of amoxicillin-clavulanate in plasma
Timeframe: Up to Day 10
Time-kill curve of amoxicillin-clavulanate against four common bacterial strains
Timeframe: Up to Day 10
Peak plasma drug concentration (Cmax) of amoxicillin-clavulanate
Timeframe: Up to Day 10
Terminal elimination half-life (T1/2) of amoxicillin-clavulanate in plasma
Timeframe: Up to Day 10
Secondary outcomes:
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Timeframe: Up to Day 14
Vital sign measurement as a measure of safety and tolerability
Timeframe: Up to Day 14
Clinical laboratory parameters as a measure of safety and tolerability
Timeframe: Up to Day 14
Interventions:
Enrollment:
0
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Infections, Respiratory Tract
Product
amoxicillin, amoxicillin/clavulanic acid, clavulanic acid
Collaborators
Not applicable
Study date(s)
August 2014 to October 2014
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
20 - 50 Year
Accepts healthy volunteers
yes
- Subjects who are Thai male or female aged 20 to 50 years (inclusive).
- Subjects whose body mass index (BMI) is within 18-25 kilogram/square meter (kg/m^2) (inclusive).
- Subjects who are with a history/evidence of allergy or hypersensitivity to amoxicillin, penicillin, cephalosporin, clavulanic acid or any related drug.
- Subjects who have a history of any illness that, in the opinion of the Clinical Investigator, might confound the result of the study or pose an additional risk in administrating study drug to the subjects. This may include but not limited to: a history of relevant drug or food allergies; history or cardiovascular, gastrointestinal, central nervous system disease, renal and hepatic impairment; history or presence of clinically significant illness; or history of mental illness that may affect compliance with study requirements.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who are Thai male or female aged 20 to 50 years (inclusive).
- Subjects whose body mass index (BMI) is within 18-25 kilogram/square meter (kg/m^2) (inclusive).
- Subjects who are healthy by medical history, physical examination and vital signs.
- Subject whose screening visit laboratory values of blood tests including complete blood count, fasting blood sugar, blood urea nitrogen, serum creatinine, alkaline phosphatase, ALT, AST, total bilirubin, albumin, electrolytes, Hepatitis Bs-antigen, Hepatitis C-antigen, anti- human immunodeficiency virus (HIV) and serum Immunoglobulin G (IgG) for amoxicilloyl are within the normal range or showing no clinically significant abnormalities as confirmed by the Clinical Investigator.
- For female subjects: Female subject who is in childbearing potential must have serum beta- human chorionic gonadotropin (HCG)- negative and agrees to use an acceptable birth control method from visit 1 to the last visit. The acceptable birth control method is defined as a barrier method of contraception (including condoms, intrauterine device (IUD) and diaphragm with spermicidal agent) or total abstinence from sexual intercourse from visit 1 to the last visit. Hormonal contraceptives are not acceptable. Female subject who is in child bearing potential must agree not to become pregnant for the entire participation phase and must have a negative result for urine pregnancy test performing prior to dosing at phase I and II. Female subjects can be those with non-childbearing potential which defined as female subjects with hysterectomy, both ovaries removed, surgically sterilized or postmenopausal (for at least 12 consecutive months of amenorrhea).
- Subjects are able to understand the requirements of the study and voluntarily sign and date an informed consent, approved by the Independent Ethic Committee/Institutional Review Board, prior to the initiation of any screening or study-specific procedures.
Exclusion criteria:
- Subjects who are with a history/evidence of allergy or hypersensitivity to amoxicillin, penicillin, cephalosporin, clavulanic acid or any related drug.
- Subjects who have a history of any illness that, in the opinion of the Clinical Investigator, might confound the result of the study or pose an additional risk in administrating study drug to the subjects. This may include but not limited to: a history of relevant drug or food allergies; history or cardiovascular, gastrointestinal, central nervous system disease, renal and hepatic impairment; history or presence of clinically significant illness; or history of mental illness that may affect compliance with study requirements.
- Subjects who are with a history of heavy smoking (more than 10 cigarettes per day) or moderate smoking (less than 10 cigarettes per day) and cannot omit smoking at least one day before the study and until the completion of the study phase.
- Subjects who are with a history of alcoholic (more than 2 years) or moderate drinkers (more than 3 drinks per day – one is equal to one unit of alcohol:
- one glass of wine, half pint of beer or one measure of spirit) or subjects who are with a history of any drug abuse.
- Subjects who receive of any medical prescription within 14 days before the first administration of the study drug, especially drug related to the study drug metabolizing enzyme.
- Female subjects who are pregnant or breast feeding.
- Subjects who are participating in any investigational drug study or had been in any investigational drug study within 3 month prior to the screening visit.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Other
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
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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