Trial Outcomes & Findings for Paxil CR Bioequivalence Study Brazil - Fed Administration (NCT NCT01339247)

Last Updated: 2018-06-20

Results Overview

The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC\_ss is the area under the curve during the steady-state period. The AUC\_ss is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; h, hour; ml, milliliter; ng.h/ml, nanograms per hour per milliliter.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

60 participants

Primary outcome timeframe

Days 14 to 17 (period 1) and Days 23 to 24 (Period 2)

Results posted on

2018-06-20

Participant Flow

Participant milestones

Participant milestones
Measure	Test Product in Period 1; Reference Product in Period 2 Test product: paroxetine hydrochloride tablet with controlled release (Paxil CR) 25 milligrams (mg) manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 1; followed by reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2	Reference Product in Period 1; Test Product in Period 2 Reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 1; followed by test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 2
Period 1 STARTED	30	30
Period 1 COMPLETED	30	30
Period 1 NOT COMPLETED	0	0
Period 2 STARTED	30	30
Period 2 COMPLETED	30	30
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Paxil CR Bioequivalence Study Brazil - Fed Administration

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants Receiving Both Test and Reference Product n=60 Participants Participants receiving either test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 1; followed by reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2 or reference product in Period 1 and test product in Period 2
Age, Continuous	27.73 Years STANDARD_DEVIATION 4.65 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	35 participants n=5 Participants
Race/Ethnicity, Customized Black	4 participants n=5 Participants
Race/Ethnicity, Customized Mixed Race	21 participants n=5 Participants

PRIMARY outcome

Timeframe: Days 14 to 17 (period 1) and Days 23 to 24 (Period 2)

Population: Entire study population

Outcome measures

Outcome measures
Measure	Test Product n=60 Participants Test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in both periods	Reference Product n=60 Participants Reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in both periods
AUC_ss	672.9221 ng.h/ml Standard Deviation 432.2451	645.5407 ng.h/ml Standard Deviation 413.9084

PRIMARY outcome

Timeframe: Days 14 to 17 (period 1) and Days 23 to 24 (Period 2)

Population: Entire study population

Cmin\_ss is defined as the minimum concentration of a drug observed after its administration, in steady-state. Cmin\_ss is one of the parameters of particular use in estimating the bioavailability of drugs, for studies employing multiple doses.

Outcome measures

Outcome measures
Measure	Test Product n=60 Participants Test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in both periods	Reference Product n=60 Participants Reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in both periods
Cmin_ss	19.4468 ng/ml Standard Deviation 13.7780	18.9010 ng/ml Standard Deviation 12.6797

PRIMARY outcome

Timeframe: Days 14 to 17 (period 1) and Days 23 to 24 (Period 2)

Population: Entire study population

Cmax\_ss is defined as the maximum or "peak" concentration of a drug observed after its administration, in steady-state. Cmax\_ss is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed.

Outcome measures

Outcome measures
Measure	Test Product n=60 Participants Test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in both periods	Reference Product n=60 Participants Reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in both periods
Cmax_ss	36.7235 ng/ml Standard Deviation 21.0928	36.6630 ng/ml Standard Deviation 21.9946

Adverse Events

Period 1

Serious events: 0 serious events

Other events: 48 other events

Deaths: 0 deaths

Period 2

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	Period 1 n=60 participants at risk Participants receiving test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada or reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 1	Period 2 n=60 participants at risk Participants receiving test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada or reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2
Cardiac disorders Tachycardia	0.00% 0/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.	1.7% 1/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.
Eye disorders Mydriasis	1.7% 1/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.	0.00% 0/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.
Gastrointestinal disorders Watery stools	0.00% 0/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.	1.7% 1/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.
Gastrointestinal disorders Nausea	26.7% 16/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.	0.00% 0/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.
Gastrointestinal disorders Epigastralgia	6.7% 4/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.	0.00% 0/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.
Gastrointestinal disorders Heartburn	5.0% 3/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.	0.00% 0/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.
Gastrointestinal disorders Intestinal colic	3.3% 2/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.	0.00% 0/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.
Gastrointestinal disorders Abdominal pain	0.00% 0/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.	1.7% 1/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.
Gastrointestinal disorders Mild retch	1.7% 1/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.	0.00% 0/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.
General disorders Cephalea	30.0% 18/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.	11.7% 7/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.
General disorders Fever	1.7% 1/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.	0.00% 0/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.
General disorders Malaise	5.0% 3/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.	0.00% 0/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.
General disorders Weakness	0.00% 0/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.	1.7% 1/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.
General disorders Pain on the whole body	0.00% 0/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.	1.7% 1/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.
Metabolism and nutrition disorders Hyporexia	8.3% 5/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.	0.00% 0/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.
Metabolism and nutrition disorders Lack of appetite	6.7% 4/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.	1.7% 1/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.
Nervous system disorders Somnolence	36.7% 22/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.	13.3% 8/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.
Nervous system disorders Insomnia	6.7% 4/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.	3.3% 2/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.
Nervous system disorders Dizziness	0.00% 0/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.	5.0% 3/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.
Nervous system disorders Tremor	3.3% 2/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.	1.7% 1/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.
Nervous system disorders Dysgeusia	1.7% 1/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.	0.00% 0/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.
Nervous system disorders Thinking abnormal	0.00% 0/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.	1.7% 1/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.
Nervous system disorders Sensation of slowness	1.7% 1/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.	0.00% 0/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.
Psychiatric disorders Irritability	1.7% 1/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.	0.00% 0/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.
Psychiatric disorders Agitation	1.7% 1/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.	0.00% 0/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.
Reproductive system and breast disorders Menstrual colic	1.7% 1/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.	0.00% 0/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.
Reproductive system and breast disorders Retardation of ejaculation	1.7% 1/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.	0.00% 0/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.
Reproductive system and breast disorders Ejaculation difficulty	3.3% 2/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.	1.7% 1/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.
Respiratory, thoracic and mediastinal disorders Sinusitis	1.7% 1/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.	0.00% 0/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.
Respiratory, thoracic and mediastinal disorders Sore throat without evidence of infection	1.7% 1/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.	0.00% 0/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.
Respiratory, thoracic and mediastinal disorders Sore throat with hyperaemia in tonsils	1.7% 1/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.	0.00% 0/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.
Infections and infestations Tonsillitis	3.3% 2/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.	0.00% 0/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.
Skin and subcutaneous tissue disorders Perspiration	1.7% 1/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.	0.00% 0/60 In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.