Pharmacokinetic Study to Compare Two Formulations of Paracetamol

A Pharmacokinetic Study to Evaluate the Rate and Extent of Absorption of Paracetamol From Two Formulations in an Indian Population.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01767428

Enrollment

Registered

2013-01-14

Start date

2010-04-30

Completion date

2010-04-30

Last updated

2013-01-14

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

Conditions

Fever, Headache Disorders, Pain

Brief summary

A pharmacokinetic study in healthy volunteers comparing two formulations of paracetamol fast release in fasted state.

Interventions

DRUGParacetamol

500 mg immediate release paracetamol formulations

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male volunteers aged 18-55yrs willing to give written informed consent for the study * BMI must be within the range 18.5 - 24.9 kg/m\^2 * Participant with a minimum weight of 50 kg

Exclusion criteria

* Participant with current or recurrent disease that could affect the action, absorption or disposition of the study medication or clinical or laboratory assessments (e.g. hepatic disorders, renal insufficiency, congestive heart failure) * Participant with known or suspected intolerance or hypersensitivity to the study materials * Participant who are vegetarian * Participant smoking more than five cigarettes a day

Design outcomes

Primary

Measure	Time frame	Description
AUC (0-inf)	Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose.	Area under the plasma concentration time curve from zero and extrapolated to infinite time.
Cmax	Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose.	Maximum plasma concentration of paracetamol.
AUC (0-t)	Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose.	Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample.

Secondary

Measure	Time frame	Description
Tmax	Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose.	Time taken to reach maximum plasma concentration of paracetamol.

Outcome results

None listed

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