Amoxicillin Bioequivalence Study Brazil - Fast

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT01431989

First received: September 8, 2011

Last updated: January 4, 2013

Last verified: January 2013

History of Changes

Results First Received: January 5, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Bio-equivalence Study; Intervention Model: Crossover Assignment; Masking: Open Label
Condition:	Infections, Bacterial
Interventions:	Drug: Amoxicillin powder for oral suspension (Clamoxyl®) 500mg/5mL Drug: Amoxil® 500mg/5mL powder for oral suspension

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This is a prospective, open-label, randomized, crossover, single-dose study in which two different treatments (Test Product versus Reference Product) were administered in two sequences in two study periods. The objective was to confirm if two formulations of Amoxicillin trihydrate, in the form of powder for oral suspension, are bioequivalent.

Reporting Groups

	Description
Test Product in Period 1: Reference Product in Period 2	Test product, Amoxicillin (Clamoxyl) 500 milligrams (mg)/5 milliliter (mL) powder for oral suspension, in Period 1; followed by a 14-day washout period during which no medication was administered; followed by reference product, Amoxil 500 mg/5 mL powder for oral suspension, in Period 2
Reference Product in Period 1: Test Product in Period 2	Reference product, Amoxil 500 mg/5 mL powder for oral suspension, in Period 1; followed by a 14-day washout period during which no medication was administered; followed by test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, in Period 2

Participant Flow for 3 periods

Period 1: Period 1

	Test Product in Period 1: Reference Product in Period 2	Reference Product in Period 1: Test Product in Period 2
STARTED	14	14
COMPLETED	14	14
NOT COMPLETED	0	0

Period 2: 14-Day Washout Period

	Test Product in Period 1: Reference Product in Period 2	Reference Product in Period 1: Test Product in Period 2
STARTED	14	14
COMPLETED	14	14
NOT COMPLETED	0	0

Period 3: Period 2

	Test Product in Period 1: Reference Product in Period 2	Reference Product in Period 1: Test Product in Period 2
STARTED	14	14
COMPLETED	14	14
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Participants Receiving Both Test and Reference Products	Participants receiving either test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, in Period 1; followed by a 14-day washout period during which no medication was administered; followed by reference product, Amoxil 500 mg/5 mL powder for oral suspension, in Period 2 or reference product in Period 1 and test product inPeriod 2

Baseline Measures

	Participants Receiving Both Test and Reference Products
Number of Participants [units: participants]	28
Age [units: Years] Mean ± Standard Deviation	34.54 ± 7.38
Gender [units: Participants]
Female	14
Male	14
Race/Ethnicity, Customized [units: participants]
White	10
Black	4
Mulatto	14

Outcome Measures

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1. Primary:

Area Under the Curve of Plasma Concentration of Drug From Time 0 (Zero) to t (Last Measurable Concentration) (AUC0-t) [ Time Frame: Collection points (hours [hrs]): 0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study]) ]

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2. Primary:

Maximum Observed Concentration of Drug Through Time (Cmax) [ Time Frame: Collection points (hrs): 0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study]) ]

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3. Primary:

Area Under the Curve of Plasma Concentration of Drug From Time 0 (Zero) Extrapolated to Infinity (AUC0-inf) [ Time Frame: Collection points (hrs):0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods (Day 1 of Period 1[Day 1 of study]; Day 1 of Period 2 [Day 15 of study]) ]

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4. Primary:

Time of Maximum Observed Concentration (Tmax) [ Time Frame: Collection points (hrs):0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods: (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study]) ]

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5. Primary:

Percentage of AUC0-inf That is Due to Extrapolation From the Time of the Last Measurable Concentration to Infinity (AUC%Extrapolation) [ Time Frame: Collection points (hrs):0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods: (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study]) ]

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6. Primary:

Terminal Half-life (T1/2_Kel) [ Time Frame: Collection points (hrs):0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods: (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study]) ]

Show Outcome Measure 6

7. Primary:

First-order Rate Constant Associated With the Terminal Portion of the Curve (Kel) [ Time Frame: Collection points (hrs):0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods: (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study]) ]

Show Outcome Measure 7

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01431989 History of Changes
Other Study ID Numbers:	115954
Study First Received:	September 8, 2011
Results First Received:	January 5, 2012
Last Updated:	January 4, 2013
Health Authority:	Brazil: Institutional Review Board

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