Phase 1
Completed N=38
Bioequivalence Study of Paroxetine and PAXIL Under Fasting Conditions in Healthy Mexican Participants
Source: ClinicalTrials.gov NCT04311463 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcomePrimary: Maximum Observed Plasma Concentration (Cmax) of Paroxetine — 8.39; 8.83 Nanograms per milliliter
Summary
This study will be conducted to evaluate and compare the single oral dose bioavailability of Paroxetine manufactured by GlaxoSmithKline (GSK) Pharmaceuticals S.A. for GlaxoSmithKline México, S.A. de C.V. with that of PAXIL® (Paroxetine) of GlaxoSmithKline, México, S.A. de C.V. in healthy, adult, male and female participants under fasting conditions. Maximum 38 participants will be randomized and dosed. The expected duration of this study will be 12 days including 7 days of washout period in-between each dosing. PAXIL is a registered trademark of GSK group of companies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Paroxetine |
8.39; 8.83 | — |
| PRIMARY Area Under the Concentration-time Curve (AUC) From Time Zero to the Last Measurable Concentration (AUC[0-t]) of Paroxetine |
128.876; 150.549 | — |
| PRIMARY Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Paroxetine |
142.482; 160.143 | — |
| PRIMARY Percentage of AUC (0 to Infinity) Obtained by Extrapolation (%AUCex) of Paroxetine |
7.95; 7.05 | — |
| PRIMARY Time of the Maximum Measured Plasma Concentration (Tmax) of Paroxetine |
5.00; 5.00 | — |
| PRIMARY Elimination Half-life (t1/2) of Paroxetine |
10.78; 11.32 | — |
| PRIMARY Terminal Elimination Rate Constant (Kel) of Paroxetine |
0.0653; 0.0618 | — |
| SECONDARY Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) |
7; 7; 0; 0 | — |
| SECONDARY Number of Participants With Abnormal Vital Signs |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy adult male and female participants aged between 18 and 55 years.
- Participant is a light smoker (someone who smokes 9 or less cigarettes per day) or non- or an ex-smoker (someone who completely stopped smoking for at least 6 months before day 1 of this study).
- With a weight greater than or equal to (>=)50.00 kilograms (kg).
- With a body mass index (BMI) >=18.5 kilograms per meter square (kg/m^2) and less than or equal to ( =10 cigarettes per day during the last 6 months prior to period -1 dosing.
- Have history or presence of cancer.
- Have any history of gastrointestinal ulcers/intestinal bleeding.
- Have history of difficulty for donating blood.
- Have clinically significant abnormal laboratory tests results.
- Have a systolic blood pressure less than ( )140 millimeters of mercury (mmHg) or diastolic blood pressure is 90 mmHg.
- Have a pulse rate 100 beats/minute (lower range of pulse range will be accepted up to 45 beats/minute in case of athlete).
- Have used any prescribed medication during the last 14 days preceding the first dosing, or use over-the-counter (OTC), medicinal or herbal products during the last 7 days or use medicinal enzyme inhibitors / inducers during last 30 days preceding the first dosing.
- Have participated in a drug research study or donated blood within the last 3 months.
- Have a positive result for drugs of abuse test (cannabinoids [marijuana/tetrahydrocannabinol-(THC)], cocaine, opiates/morphine, amphetamine, methamphetamine and benzodiazepines] performed during screening.
- Female participant, who is currently breast feeding or a who is pregnant or who is likely to become pregnant during the study.
- Female participant has a positive pregnancy test results.
- Unwillingness or inability to comply with the instructions on the lifestyle.
- If the PI considers, for any reason, that the volunteer is not a suitable candidate to receive the study drug.
Data sourced from ClinicalTrials.gov (NCT04311463). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.