Trials / Completed
CompletedNCT04311463
Bioequivalence Study of Paroxetine and PAXIL Under Fasting Conditions in Healthy Mexican Participants
An Oral Single-dose, Randomized, Balanced, Open-label, Two-sequence, Two-treatment, Two-period, Crossover Bioequivalence Study of Paroxetine Tablets 20 mg of GlaxoSmithKline Pharmaceuticals S.A, With That of PAXIL (Paroxetine) Tablets 20 mg of GlaxoSmithKline México S.A. de C.V., in Healthy Adult Male and Female Subjects Under Fasting Conditions
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 38 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Paroxetine hydrochloride | Paroxetine hydrochloride will be administered. |
| DRUG | PAXIL (Paroxetine hydrochloride ) | PAXIL will be administered. |
Timeline
- Start date
- 2020-12-09
- Primary completion
- 2021-01-02
- Completion
- 2021-01-02
- First posted
- 2020-03-17
- Last updated
- 2022-01-20
- Results posted
- 2022-01-20
Locations
1 site across 1 country: Mexico
Source: ClinicalTrials.gov record NCT04311463. Inclusion in this directory is not an endorsement.