Pharmacokinetic Study of Iron Dextran intravenous injection in Iron deficiency anemia patients
- Conditions
- Health Condition 1: D509- Iron deficiency anemia, unspecified
- Registration Number
- CTRI/2020/06/026200
- Lead Sponsor
- Mylan Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 295
1. Age:18 to 65 years
2. Sex: Males and/or non-pregnant, non-lactating females.
3. Weight: Patients with body weight equal or greater than 50 kg and BMI of 18.5 â?? 30.0 kg/m2.
4. Non-Smokers
5. Patients diagnosed with iron deficiency anemia, in whom iron deficient state is not amenable to oral iron supplementation and who require parenteral iron dextran for
the initial treatment
6. Have not received parenteral iron supplementation in the past.
7. Patients considered to be suitable for treatment with iron dextran injection based on Investigatorâ??s clinical judgement.
9. Adequate venous access in both arms
10. Able to understand and sign written Information Consent Form
11. Willing to follow the protocol requirements and comply with protocol restrictions
12. All subjects should be judged by the Principal Investigator or Medical Sub-Investigator as normal and healthy during a pre-study medical evaluation which include adequate hemopoietic, liver and renal function.
1. Institutionalized subjects.
2. Social Habits include ingestion of alcohol, vitamins or herbal products, nicotine/tobacco containing products and history of drug/alcohol abuse.
3. Medications:
a. Parenteral iron therapy
b. Oral iron therapy
c. Erythropoiesis stimulating agents
d. Currently on treatment with angiotensin converting enzyme inhibitor drugs or beta blockers
e. Concomitant medications that may affect the pharmacokinetic (PK) results
4. Diseases:
a. Patients considered to be anemic due to other etiology.
b. History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological,
genitourinary, musculoskeletal disease or any other condition or a laboratory value, that in the principal investigatorâ??s judgement, might increase the risk to the
patient
c. Patients with known active malignancy
d. Patients on hemodialysis or in having acute phase of infectious kidney diseases
e. History of tuberculosis
f. Patient with history of rheumatoid arthritis
g. Hemochromatosis or other iron storage disorders
h. History of Blood loss.
i. History of major surgery or invasive intervention, organ transplant . Acute illness at the time of either the pre-study medical evaluation or dosing
k. history of significant allergies and/or asthma
5. Any reason which, in the opinion of the Principal Investigator or Medical Sub-Investigator, would prevent the subject from safely participating in the study
6. Intolerance to venipuncture
7. Received whole blood transfusion or red blood cell transfusion or donated blood (1 unit or 350 mL) within 90 days prior to randomization
8. Donation or loss of blood or plasma
9. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication
10. Any food allergy, intolerance, restriction or special diet
11. Allergy or hypersensitivity to iron dextran, other related products, or any inactive ingredients
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method