Comparative bioequivalence study of the Pazopanib 200-mgTablets manufactured by Noavaran Daroui Kimia Company

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20130313012810N13

Enrollment

Registered

2023-09-12

Start date

2023-09-21

Completion date

Unknown

Last updated

2023-10-16

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: Intervention group 1: Intervention group 1 consists of healthy and fasting male volunteers who will receive a single dose of 200 mg pazopanib tablets manufactured by the domestic pharm

Eligibility

Sex/Gender

Male

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: The weight range of participating candidates should be between 60-100 kg All candidates must be non-smokers Candidates should be healthy in terms of physical examination, ECG and the following laboratory tests: Hemoglobin, Hematocrit, Red and White Blood Count, MCV (Mean Body Volume), MCH (Mean Body Hemoglobin), Routine Urinalysis, Total Cholesterol, Triglyceride, Total Proteins, albumin, uric acid, total bilirubin, alkaline phosphatase, gamma glutamyl transpeptidase (?-GT), aspartate aminotransferase (AST), alanine aminotransferase (ALT), urea, creatinine and fasting blood glucose Volunteers who have agreed to an informed consent form All candidates should not consume caffeine-containing drinks and chocolate during two days before the prescription, and this restriction must be followed until the last blood draw

Exclusion criteria

Exclusion criteria: History of allergic or adverse reaction to Pazopanib or any similar product Volunteers with blood pressure less than 60/90 mm Hg or higher than 90/140 mm Hg Smokers Individuals who donated whole blood or blood components within 2 months within 2 weeks prior to the first dose of the study product(s) Due to the possibility of QT prolongation complications, volunteers with a family history of heart diseases, especially rhythm disorders, are excluded from the study.

Design outcomes

Primary

Measure	Time frame
Plasma concentration of the drug. Timepoint: 16 sampling time till 72 h. Method of measurement: Liquid Chromatography with tandem mass spectrometry (LC-MS-MS).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamed Hamishehkar

Tabriz University of Medical Sciences

hamishehkar.hamed@gmail.com+98 41 3336 3181

Outcome results