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The effect of piperine on Midazolam concentration

The role of piperine on Midazolam plasma concentration in healthy volunteers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201203129271N1
Enrollment
20
Registered
2012-09-16
Start date
2011-03-20
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Pharmacokinetics. General examination and investigation of persons without complaint and reported diagnosis

Interventions

Intervention 1: Control group: administration placebo one capsule daily for three days before midazolam (10 mg oral single dose). Intervention 2: Piperine group: administration piperine (15 mg) one ca
Treatment - Drugs
Control group: administration placebo one capsule daily for three days before midazolam (10 mg oral single dose).
Piperine group: administration piperine (15 mg) one capsule daily for three days before midazolam (10 mg oral single dose).

Sponsors

Babol University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: After providing adequate information to the subjects, eligible healthy volunteer will be enrolled in the study. Inclusion criteria: be healthy; normal diet; not receiving microsomal enzyme inhibitor or inducer agents for at least 7 days before the study; not using black pepper for at least 7 days before the study. Exclusion criteria: age below 18 and above 35; smoking; pregnancy; metabolic disorders; high pepper diet, receiving enzyme inhibitors or inducers.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Midazolam Placema Concentration. Timepoint: Only once in fourth day of the study 0.5, 2.5 and 5 h after taking midazolam. Method of measurement: Using HPLC method (reverse phase; Water 25, Methanol 75, flow rate 0.8 ml/min, maximum wave lengh 242 nm).

Secondary

MeasureTime frame
-. Timepoint: -. Method of measurement: -.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Ali Akbar Moghadamnia

Babol University of Medical Sciences

a.moghadamnia@mubabol.ac.irmoghadamnia@yahoo.com+98 11121995926

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026