Ursodeoxycholic acid in cholelithiasis

Evaluation of bioequivalency of Ursodeoxycholic acid capsule of Ahran Tejarat Company compared to Ursoflor® on 24 volunteers.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120624010104N7

Enrollment

Registered

2021-01-24

Start date

2021-06-22

Completion date

Unknown

Last updated

2021-02-22

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

Conditions

None listed

Interventions

Intervention 1: Each volunteer take 2 times the medication at least a week apart. Intervention group: 1 -24 volunteers after their

Eligibility

Sex/Gender

Male

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Complete clinical health Age 18 to 60 years Male volunteers

Exclusion criteria

Exclusion criteria: Underlying diseases Hypertension Kidney Liver and gastrointestinal diseases Smoking and alcohol consumption Chronic drug use Temporary drug use less than 10 days after sampling

Design outcomes

Primary

Measure	Time frame
Determination of drug concentration in plasma. Timepoint: Blood sampling during 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 24, 48, 72 hour after taking the drug. Method of measurement: UV-HPLC.	—

Secondary

Measure	Time frame
Pharmacokinetic parameters. Timepoint: Immediately after the intervention. Method of measurement: Theoretically and using pharmacokinetic equations.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehdi Ansari

Kerman University of Medical Sciences

mansari@kmu.ac.ir+98 913 141 5342

Outcome results