A randomized, double-blind, two-treatment, single-period, single-dose, parallel design, comparative bioavailability study between RTPR- 021 (test adalimumab) and Humira® (reference adalimumab).
- Registration Number
- CTRI/2015/02/005524
- Lead Sponsor
- Reliance Life Sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 120
1. Healthy adult male and female subjects, aged between 18 to 45 years (both inclusive).
2. Subjects with Body Mass Index (BMI) 18 to 24.9 kg/m2
3. If subject is a female and is
- of child bearing potential, she should be practicing an acceptable method of birth
control for the duration of the study as judged by the investigator(s), such as condoms,
foams, jellies, diaphragm, intrauterine device (IUD), or abstinence
OR
- surgically sterile, bilateral tubal ligation should be documented
4. Subjects able and willing to comply with the protocol requirements.
5. Subjects willing to voluntarily provide written informed consent.
6. Subjects willing to undergo pre and post-study physical examinations and laboratory investigations.
7. Subjects who are non-smokers based on history.
8. Subjects willing to adhere to the protocol and the following study requirements:
• Should not consume xanthine containing products, such as coffee, tea, chocolate or soft drinks at least 48 hours prior to dosing (i.e. in-house monitoring and the remaining based on history) until the last sample collection.
• Should not consume alcohol at least 48 hours prior to dosing (i.e. during in-house monitoring and the remaining based on history) until the last sample collection.
• Should not consume grapefruit or its products at least 7 days prior to dosing (i.e. during in-house monitoring and the remaining based on history) and until the last sample collection
9. Subjects having no clinically significant medical history and no clinically significant abnormalities in general physical examination, laboratory assessments, ECG, chest X-Ray or vital signs.
1. Subjects incapable of understanding the informed consent process.
2. Pregnant female subjects with a positive pregnancy test at screening or positive serum β-HCG test or lactating females.
3. Female subjects of childbearing potential who are unwilling or unable to use an appropriate method of contraception as outlined in the inclusion criteria, at least 14 days prior to the first dose of study medication until the post-study follow-up (i.e. until 60 days after the drug administration). Use of hormonal contraceptives that are either oral or implants will not be acceptable.
4. Subjects with inadequate venous access in their left or right arm to allow the collection of all samples via venous cannula in the study.
5. Subjects with abnormalities in resting heart rate (100 beats/min or 50 beats/min), blood pressure either hypotensive episode (systolic blood pressure 90 mmHg or diastolic blood pressure 60 mmHg) or hypertension (systolic blood pressure >= 140 mmHg or diastolic blood pressure >=90 mmHg), oral temperature ( 95.60F or 990F) on the screening day.
6. Subjects with active history of psychiatric disorders, which are likely to limit the validity of consent to participate in the study, or limit the ability to comply with the protocol requirements.
7. Subjects with any evidence of organ dysfunction or any clinically significant deviation from normal in their physical or clinical evaluation including ECG and X-ray results.
8. Subjects who have taken over the counter or prescribed medications, including any enzyme modifying drugs or any systemic medication within 30 days prior to the start of the clinical period and during the study period.
9. Subjects with a known history of drug hypersensitivity to adalimumab or any excipients of the formulation.
10. Subjects with a history of alcohol abuse and/or drug abuse or who are found urinary screen test positive for drugs of abuse (Amphetamines, Morphine, Benzodiazepines, Marijuana, Cocaine and Barbiturates) or are found with current alcohol abuse based on alcohol breath test.
11. Subjects diagnosed to be HIV 1 and 2 or Hepatitis B (HBsAg) or Hepatitis C (HCV) virus positive.
12. Subjects with clinically significant abnormal haematological values [haemoglobin (Hb), total white blood cells count (WBC), total red blood cells count (RBC), differential WBC count, platelet count and hematocrit].
13. Subjects with history of active infection in last 1 month.
14. Subjects with clinically significant abnormal laboratory values for serum creatinine, blood urea nitrogen (BUN), serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase (ALP), serum bilirubin, serum glucose (fasting), serum cholesterol and serum electrolytes.
15. Subjects with clinically significant abnormal urine analysis, defined as the presence of RBC (5/HPF), pus cells (5/HPF), epithelial cells (5/HPF), glucose (positive), ketones (positive), bilirubin (positive) and protein (positive) (unless the clinical investigator considers the deviation to be irrelevant for the purpose of the study).
16. Subjects with a clinically significant past history or current medical condition of:
a. Pulmonary disorders (COPD and asthma)
b. Cardiovascular disorders (especially heart blocks including second or third degree A-V block and right bundle branch block, myocardial infarction, cong
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To establish bioequivalence of Test vs Reference product in relation to the rate and extent of absorption on the basis of the following pharmacokinetic parameters: <br/ ><br>â?¢ Cmax <br/ ><br>â?¢ AUC0-t <br/ ><br>Timepoint: Primary Outcome will be assessed at following time points: Day 1 to Day 4, 8, 10, 14, 21, 28, 35, 42 and 51.
- Secondary Outcome Measures
Name Time Method To monitor adverse events, including clinically significant laboratory parameters <br/ ><br>2. Frequency of formation of antibodies to adalimumab <br/ ><br>â?¢ Immunogenicity assessment at 0, 312, 648, 984, 1200 hrs post drug administration <br/ ><br>3. To determine the following pharmacokinetic parameters of Test and Reference product <br/ ><br>â?¢ AUC0-â?? <br/ ><br>â?¢ tmax <br/ ><br>â?¢ t1/2 <br/ ><br>â?¢ Kel <br/ ><br>â?¢ MRT0â??t, <br/ ><br>â?¢ MRT0â??â?? <br/ ><br>â?¢ CL <br/ ><br>Timepoint: To monitor adverse events, including clinically significant laboratory parameters <br/ ><br>2. Frequency of formation of antibodies to adalimumab <br/ ><br>â?¢ Immunogenicity assessment at 0, 312, 648, 984, 1200 hrs post drug administration <br/ ><br>3. To determine the following pharmacokinetic parameters of Test and Reference product <br/ ><br>â?¢ AUC0-â?? <br/ ><br>â?¢ tmax <br/ ><br>â?¢ t1/2 <br/ ><br>â?¢ Kel <br/ ><br>â?¢ MRT0â??t, <br/ ><br>â?¢ MRT0â??â?? <br/ ><br>â?¢ CL <br/ ><br>