Bioequivalence Study Between Two Oral Formulations of Naproxen 500 mg Tablets Under Fasting Conditions

Randomized, 2-Way Crossover, Bioequivalence Study of Two Oral Formulations of Naproxen 500 mg Tablets Administered as 1 x 500 mg Tablet in Healthy Subjects Under Fasting Conditions

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00804401

Enrollment

Registered

2008-12-08

Start date

2004-06-30

Completion date

Unknown

Last updated

2012-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bioequivalency

Keywords

bioequivalency, Naproxen

Brief summary

Compare the rate and extent of absorption of two oral formulations of Naproxen Tablets, administered as a 1 x 500 mg tablet under fasting conditions.

Interventions

DRUGNaproxen Tablets, 500 mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* healthy men or women, non-smoker, 18 years of age or older * willing to participate and sign a copy of the informed consent form

Exclusion criteria

* clinically significant illnesses or surgery within 4 weeks prior to study dosing * body mass index greater than or equal to 30.0 * recent history of drug or alcohol addiction or abuse * pregnant or lactating women * history of allergic response to naproxen, NSAIDs, or other related drugs, or to heparin * history of allergic reactions such as asthma, rhinitis, nasal polyps, urticaria, and hypotension associated with the use of aspirin or other NSAIDs * history or known presence of gastrointestinal ulceration, bleeding and perforation * use of tobacco products within 6 months prior to study dosing * evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant * receipt of any drugs as part of a research study within 30 days prior to study dosing

Design outcomes

Primary

Measure	Time frame
Bioequivalence was assessed on the pharmacokinetic variables Cmax, AUC,0-t, and AUC,0-infinity	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026