Trial Outcomes & Findings for Paxil CR Bioequivalence Study Brazil (NCT NCT01316926)

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\_steady-state (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, nanogram; 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

Recruitment is conducted in accordance with internal Standard Operating Procedures of the research center and with the consent of the participants (Term of Recruitment and Informed Consent Form).

All candidates are informed about the study, and all undergo clinical screening.

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), once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 1; followed by reference product: Paxil CR 25 mg, once a day, 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, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra in Period 1; followed by test product: Paxil CR 25 mg, once a day, 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	29	30
Period 2 COMPLETED	29	30
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Paxil CR Bioequivalence Study Brazil

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, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 1; followed by reference product: Paxil CR 25 mg, once a day, 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	28.85 Years STANDARD_DEVIATION 4.91 • 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	37 Participants n=5 Participants
Race/Ethnicity, Customized Black	4 Participants n=5 Participants
Race/Ethnicity, Customized Mixed Race	19 Participants n=5 Participants

PRIMARY outcome

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

Population: Participants who completed the study

Outcome measures

Outcome measures
Measure	Test Product n=59 Participants Test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in both periods	Reference Product n=59 Participants Reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra in both periods
Area Under the Curve_steady-state	996.2436 ng/h/ml Standard Deviation 546.1831	1038.5812 ng/h/ml Standard Deviation 550.8923

PRIMARY outcome

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

Population: Participants who completed the study

Cmin\_steady-state (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=59 Participants Test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in both periods	Reference Product n=59 Participants Reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra in both periods
Cmin_steady-state	26.4410 ng/ml Standard Deviation 15.7817	27.9625 ng/ml Standard Deviation 15.8840

PRIMARY outcome

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

Population: Participants who completed the study

Cmax\_steady-state (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=59 Participants Test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in both periods	Reference Product n=59 Participants Reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra in both periods
Cmax_steady-state	61.0319 ng/ml Standard Deviation 34.8551	64.3281 ng/ml Standard Deviation 35.7439

Adverse Events

Period 1

Serious events: 0 serious events

Other events: 42 other events

Deaths: 0 deaths

Period 2

Serious events: 0 serious events

Other events: 13 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, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada or reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 1	Period 2 n=59 participants at risk Participants receiving test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada or reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2
General disorders Fever	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% 1/59 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	21.7% 13/60 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.	6.8% 4/59 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 Diarrhea	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% 0/59 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	31.7% 19/60 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% 1/59 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	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% 1/59 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	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% 0/59 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 Constipation	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% 0/59 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 Stomach-ache	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% 0/59 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 Vomiting	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% 0/59 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 Xerostomia	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% 0/59 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 Sore throat	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% 0/59 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 Dysphagia	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% 0/59 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 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.	1.7% 1/59 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 Epigastric pain	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% 0/59 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.
Renal and urinary disorders Dysuria	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% 0/59 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	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.	1.7% 1/59 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 Sleep disturbances	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% 0/59 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	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% 1/59 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	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% 0/59 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	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% 0/59 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 Rhinitis allergic	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% 0/59 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	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% 0/59 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	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.	1.7% 1/59 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% 0/59 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	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.	3.4% 2/59 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 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% 1/59 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.
Social circumstances Knee 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% 1/59 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.
Social circumstances Fracture right upper limb	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% 0/59 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.