Estimation of Paracetamol in Urine to Assess the Diurnal Variation

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03122561
• Date of registration: 17/04/2017
• Prospective Registration: No
• Primary sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Public title: Estimation of Paracetamol in Urine to Assess the Diurnal Variation
• Scientific title: Estimation of Paracetamol in Urine to Assess the Diurnal Variation
• Date of first enrolment: November 3, 2016
• Target sample size: 46
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03122561
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Bangladesh

Contacts

• Name: Mir Misbahuddin, PhD
• Affiliation: BSMMU

Key inclusion & exclusion criteria

Inclusion Criteria:

- The healthy male student volunteers of Eastern Medical College having age range
between 19 and 23 years

Exclusion Criteria:

- Age <19 years , >23 years

- Volunteers on analgesic or antipyretic medication

- Volunteers with history of hypersensitivity to paracetamol

- Volunteers taking any enzyme inducing or enzyme inhibiting drug

- Volunteers with impaired renal or hepatic function



Age minimum: 19 Years
Age maximum: 23 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Diurnal Variation of Paracetamol Excretion

Intervention(s)

Drug: Paracetamol 500 mg tablet at night

Drug: Paracetamol 500 mg tablet at midday

Drug: Paracetamol 500 mg tablet at morning

Primary Outcome(s)

Changes in the amount of urinary paracetamol in different times [Time Frame: [Morning: 0 hour (baseline), 4 hour (end); Mid-day: 0 hour (baseline), 4 hour (end); Night: 0 hour (baseline), 4 hour (end)] [Safety Issue: No]]

Secondary ID(s)

BSMMU-013-CT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors