Bioequivalence of AmoxicillinPhase 4NCT01933698
Bioequivalence of Two Commercial Amoxicillin Suspensions
A Phase 4 study testing amoxicillin in people with Bioequivalence of Amoxicillin, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
The aim of the present study was to compare the pharmacokinetic profiles and to evaluate the bioequivalence of two commercial amoxicillin-suspension formulations in healthy Brazilian volunteers. Read more about this study
- Who is it for?
- Ages 19 to 46 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence of Amoxicillin
- What is being tested?
- amoxicillin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2005to Jul 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 46 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- negative to HIV, hepatitis B virus, hepatitis C virus, addictive drugs and pregnancy test for women
- age between 19 and 46 years
- weight between 52 and 85 kg and body mass index between 17.6 and 28.4kg/m2
- ability to provide written consent
- laboratory exam results within the normal range for healthy individuals and/or medically acceptable defined by a clinical investigator;
- feeding habits consistent with the standardization of the study
Who cannot join
- pregnancy
- history of hypersensitivity to penicillins (normal or idiosyncratic drug reaction)
- any evidence of dysfunction or clinically significant deviation from normal
- history of any psychiatric illness that might compromise the ability to provide written consent
- history of gastrointestinal disease, hepatic, renal, pulmonary, cardiovascular, hematological, neurological or diabetes or glaucoma
- active smoker
Show all 13Show fewer
- consumption of more than 5 cups of coffee or tea per day
- history of drug dependence or abuse of alcohol consumption
- use of enzymatic-inducers drugs within 30 days or any systemic medication (including prescription drugs, such as painkillers, hepatoprotective, influenza, etc) within 14 days before the start of the study
- participation in any clinical study in 9 weeks prior to the study
- have lost or donated more than 350 mL of blood in the last three months
- have been subjected to abnormal diet for any reason (therapeutic, aesthetic, religious, etc.)
- did not have adequate venous access.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioequivalence Study of Two Commercial Amoxicillin Suspension Formulations in Healthy Human Volunteers
The aim of the present study was to compare the pharmacokinetic profiles and to evaluate the bioequivalence of two commercial amoxicillin-suspension formulations in healthy Brazilian volunteers.
Read the detailed description
Under fasting condition, 25 volunteers (13 males and 12 females) were included in this randomized, open-label, two-period crossover (1-week washout interval) bioequivalence study. Blood samples were collected at pre-dose (0h) and 0.5, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8 and 12 hours after drug ingestion. Pharmacokinetic parameters (Cmax, Tmax, T1/2, Area-under-curve0-12h and Area-under-curve0-inf) were calculated from plasma concentrations for both formulations in each subject.
- Conditions
- Bioequivalence of Amoxicillin
- Being tested
- amoxicillin
- Keywords
- Bioequivalence, Amoxicillin, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amoxicillinDrug
Also called Amoxil, Amoxi-Ped
Comparison of pharmacokinetics of both formulations
| Study group | Role | What they receive |
|---|---|---|
| Amoxi-Ped | Active comparator | Single dose of 500 mg amoxicillin - AMOXI-PED - was administered after a 12-hour overnight fast. Receives: Drug: amoxicillin |
| Amoxil | Active comparator | Single dose of 500 mg amoxicillin - AMOXIL - was administered after a 12-hour overnight fast. Receives: Drug: amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in plasmatic amoxicillin concentrations along time measured by HPLC.
Amoxicillin were extracted from plasma by precipitating plasma proteins with acetonitrile. Amoxicillin plasmatic concentration was accessed every 30 minutes until 3h hours after drug administration and every 2h after this time until 12h of drug administration. Drug plasmatic concentrations were obtained by using a HPLC method.
Measured: Change from baseline to 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2013 (estimated)
- Study startFeb 2005
- Primary completionMay 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bioequivalence of AmoxicillinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Collaborators
- Stiefel, a GSK Company
- Responsible party
- Principal investigator, Francisco Groppo, University of Campinas, Brazil
- Investigators
- Francisco C Groppo, PhD, Principal investigator, University of Campinas, BrazilAna PP Cione, Chem., Study chair, BIOAGRI Laboratórios Ltda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01933698
- Sponsor's protocol ID
- AMOXIPED-01
- Other IDs
- 63.064.653/0001-54
- Status last verified
- Aug 2013
- First submitted
- 20 Aug 2013
- Last updated
- 2 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Baglie S, Rosalen PL, Franco LM, Ruenis AP, Baglie RC, Franco GC, Silva P, Groppo FC. Comparative bioavailability of 875 mg amoxicillin tablets in healthy human volunteers. Int J Clin Pharmacol Ther. 2005 Jul;43(7):350-4. doi: 10.5414/cpp43350.
PubMed 16035378
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of Two Commercial Amoxicillin Suspension Formulations in Healthy Human Volunteers
- ClinicalTrials.gov ID
- NCT01933698
- Acronym / sponsor ID
- AMOXIPED-01
- Conditions
- Bioequivalence of Amoxicillin
- Keywords
- Bioequivalence, Amoxicillin, Human
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Collaborators
- Stiefel, a GSK Company
- Study start
- Feb 2005
- Primary completion
- May 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 2 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study was to compare the pharmacokinetic profiles and to evaluate the bioequivalence of two commercial amoxicillin-suspension formulations in healthy Brazilian volunteers.
Detailed description
Under fasting condition, 25 volunteers (13 males and 12 females) were included in this randomized, open-label, two-period crossover (1-week washout interval) bioequivalence study. Blood samples were collected at pre-dose (0h) and 0.5, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8 and 12 hours after drug ingestion. Pharmacokinetic parameters (Cmax, Tmax, T1/2, Area-under-curve0-12h and Area-under-curve0-inf) were calculated from plasma concentrations for both formulations in each subject.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amoxi-Ped | Active comparator | Drug: amoxicillinSingle dose of 500 mg amoxicillin - AMOXI-PED - was administered after a 12-hour overnight fast. |
| Amoxil | Active comparator | Drug: amoxicillinSingle dose of 500 mg amoxicillin - AMOXIL - was administered after a 12-hour overnight fast. |
Who may qualify
- Ages
- 19 to 46 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- negative to HIV, hepatitis B virus, hepatitis C virus, addictive drugs and pregnancy test for women
- age between 19 and 46 years
- weight between 52 and 85 kg and body mass index between 17.6 and 28.4kg/m2
- ability to provide written consent
- laboratory exam results within the normal range for healthy individuals and/or medically acceptable defined by a clinical investigator;
Key exclusion criteria (13 listed)
- pregnancy
- history of hypersensitivity to penicillins (normal or idiosyncratic drug reaction)
- any evidence of dysfunction or clinically significant deviation from normal
- history of any psychiatric illness that might compromise the ability to provide written consent
- history of gastrointestinal disease, hepatic, renal, pulmonary, cardiovascular, hematological, neurological or diabetes or glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amoxicillinAlso: Amoxil, Amoxi-PedComparison of pharmacokinetics of both formulations | Drug | Amoxi-Ped, Amoxil |
Primary outcome
Changes in plasmatic amoxicillin concentrations along time measured by HPLC.
Time frame: Change from baseline to 12 hours
Amoxicillin were extracted from plasma by precipitating plasma proteins with acetonitrile. Amoxicillin plasmatic concentration was accessed every 30 minutes until 3h hours after drug administration and every 2h after this time until 12h of drug administration. Drug plasmatic concentrations were obtained by using a HPLC method.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2013.
- Background: PubMed 16035378Baglie S, Rosalen PL, Franco LM, Ruenis AP, Baglie RC, Franco GC, Silva P, Groppo FC. Comparative bioavailability of 875 mg amoxicillin tablets in healthy human volunteers. Int J Clin Pharmacol Ther. 2005 Jul;43(7):350-4. doi: 10.5414/cpp43350.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco C Groppo, PhD principal investigator
University of Campinas, Brazil
Ana PP Cione, Chem. study chair
BIOAGRI Laboratórios Ltda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing amoxicillin in people with Bioequivalence of Amoxicillin, run by University of Campinas, Brazil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in plasmatic amoxicillin concentrations along time measured by HPLC. (time frame: Change from baseline to 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01933698, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2013.