| CTRI Number |
CTRI/2017/03/007993 [Registered on: 02/03/2017] Trial Registered Prospectively |
| Last Modified On: |
02/03/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
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Type of Study
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Drug |
| Study Design |
Randomized, Crossover Trial |
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Public Title of Study
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A comparative study to monitor the safety of Amphotericin 50mg per vial A and Ambisome (amphotericin b) 50 mg per vial B in 48 patients. |
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Scientific Title of Study
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A randomized, open label, two treatment, one period, multiple dose, steady-state, parallel, bioequivalence study of amphotericin b liposome for injection 50 mg per vial of sun pharmaceutical industries limited and ambisome (amphotericin b) liposome for injection 50 mg per vial of Astellas pharma in 48 patients under fed condition |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| AMC_2I_4626_16 Version 00 Amendment 00 dated 11/04/16 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
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| Name |
Dr Kirti Patel |
| Designation |
Senior Manager |
| Affiliation |
Sun Pharmaceutical Industries Limited |
| Address |
Sun Pharmaceutical Industries Ltd.,Department- Bioequivalence, Div/Room-Clinical Pharmacology Unit,
Tandalja,
Vadodara,INDIA
Vadodara
GUJARAT
390 020
India |
| Phone |
02652350789 |
| Fax |
02652354897 |
| Email |
kirti.patel@sunpharma.com |
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Details of Contact Person
Public Query
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| Name |
Mr Sharad Kholambe |
| Designation |
Manager-Business Development |
| Affiliation |
Sun Pharmaceutical Industries Ltd |
| Address |
Sun Pharmaceutical Industries Ltd. Sun House, 201 B/1, Western Express Highway, Goregaon ( E),Mumbai 400 063, India.
Mumbai
MAHARASHTRA
400063
India |
| Phone |
02243246578 |
| Fax |
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| Email |
sharad.kholambe@sunpharma.com |
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Source of Monetary or Material Support
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| Sun Pharmaceutical Industries Limited.
Tandalja,
Vadodara-390020, Gujarat, India
Phone No.: 91-265-2350789, 91-265-6615500
Fax:91-265-2354897
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Primary Sponsor
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| Name |
Sun Pharmaceutical Industries Limited |
| Address |
Sun Pharmaceutical Industries Ltd.
17/B, Mahal Industrial Estate, Mahakali Caves Road,
Andheri East, Mumbai 400093 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Dr R P Goswami |
Calcutta School of Tropical Medicine |
108, Chittaranjan Avenue, Kolkata-700073, West Bengal
Room No:20,(2nd Floor),
School of Tropical Medicine
Kolkata
WEST BENGAL |
033-2212-3697
drrpgoswami@gmail.com |
| Dr Shyam Sundar |
Kala-Azar Medical Research Centre |
Doctor’s Room (1st floor)
Ward B (2nd floor)
Ward B (1st floor),Rambag Road, Muzaffarpur-842001, Bihar
Muzaffarpur
BIHAR |
91-542-2367795
drshyamsundar@hotmail.com |
| Dr Krishna Pandey |
Rajendra Memorial Institute of Medical Sciences (RMRIMS) |
Room No: 02 (2nd Floor), Tropical Disease Research Centre (TDRC), Agamkaun, Patna-800007, Bihar
Patna
BIHAR |
91-612-2245744
drkrishnapandey@yahoo.com |
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Details of Ethics Committee
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| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Calcutta School of Tropical Medicine |
Approved |
| Ethics Committee, Kala-Azar Medical Research Centre |
Approved |
| Ethics Committee, Rajendra Memorial Institute of Medical Sciences (RMRIMS) |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
As mentioned in inclusion criteria, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
Ambisome (amphotericin b) liposome for injection 50 mg / vial |
In this Multiple dose study patients will be randomized to receive an infusion [using controlled infusion device] of reference product Amphotericin B Liposome for Injection [Final Dilution of 2 mg/mL in 5% Dextrose] will be administered by intravenous route, site preferably near to the cubital fossa over 120 minute period, 2.5 hours after start of Standard (Non-high fat) breakfast (500-600 Kcal) in the morning as per randomization schedule for five consecutive days [Day 01 to 05]. |
| Intervention |
Amphotericin B Liposome for Injection 50 mg / vial |
In this Multiple dose study patients will be randomized to receive an infusion [using controlled infusion device] of test product Amphotericin B Liposome for Injection [Final Dilution of 2 mg/mL in 5% Dextrose] will be administered by intravenous route, site preferably near to the cubital fossa over 120 minute period, 2.5 hours after start of Standard (Non-high fat) breakfast (500-600 Kcal) in the morning as per randomization schedule for five consecutive days [Day 01 to 05] |
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Inclusion Criteria
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| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
i. Patients who need Amphotericin B treatment for no less than 5 days as part of his/her therapy as per Appendix IV.
Any of the below patients category can be enrolled
(a) Patients with cryptococcal Meningitis with HIV infection
(b)Febrile, neutropenic patients that require empirical therapy for presumed fungal infection
(c)Patients with Aspergillus species, Candida species and/or Cryptococcus species infections [see above (a) for Cryptococcal Meningitis] refractory to Amphotericin B Deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of Amphotericin B Deoxycholate.
(d)Patients with visceral leishmaniasis (Immunocompetent & Immunocompromised patients, to be decided at the discretion of Investigator)
ii. Patient whose age is in between 18-75 years (Limits inclusive).
iii. Patient willing to give written consent (Patient Information Sheet and Informed Consent Form) prior to enrolment in the study.
iv. Patients whose life expectancy is greater than or equal to 6 months.
v. Patients with Performance less than or equal to 2 on the ECOG performance scale #.
vi. Patients must have clinically acceptable results from all the screening and check-in laboratory parameters and investigations.
vii. Availability of patient for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
viii. Subjects
• of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as birth control pills (if taken for at least 3 months prior to receiving the study medication), progestin injection or implants, condom plus spermicide, diaphragm plus spermicide, IUD, or vaginal spermicidal suppository or abstinence from sexual activity.
OR
• Postmenopausal for at least past 12 months.
OR
• Surgically sterile (bilateral tubal ligation / bilateral oophorectomy / hysterectomy has been performed on the subject).
# Applicable for patient population mentioned in inclusion criterion i. (b)
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| ExclusionCriteria |
| Details |
i. Patient with a history of or current clinically significant medical illness including (but not limited to) cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological, or psychiatric disease or any other illness that the investigator considers should exclude the patient.
ii. Patients with clinical evidence of acute or chronic meningitis due to an agent other than Cryptococcus neoformans [For HIV Infected patient only].
Patients who have evidence of underlying disease which in the judgment of the investigator would make the patient inappropriate for getting enrolled in the study (except inclusion criteria point i, a, b, c, d) during screening medical history.
iii. Patient with a comorbid complication with anticipated difficulty in protocol compliance in the opinion of the investigator as a result of the comorbid complication or the drugs used to treat it.
iv. Patient with Suspected or active tuberculosis (TB).
v. Allergy or Significant history of hypersensitivity or idiosyncratic reactions to any drug or excipients of conventional or Liposomal Amphotericin B formulations.
vi. Patients who have shown positive result in breath alcohol test and/or urine drug screening test prior to check in.
vii. Patients with serum creatinine concentration >2 x the upper limit of normal (ULN) or ASAT/ALAT value >10 x ULN.
viii. Clinically significant illness (except inclusion criteria point i, a, b, c, d) within 4 weeks before the start of the study.
ix. Patients with a history of alcohol, drug or substance abuse in the past 12 months.
x. Patients who have used enzyme modifying drugs (like Phenytoin, Carbamazepine, Barbiturates, Griseofulvin etc.) within 30 days of first dosing.
xi. Patients deemed uncooperative or noncompliant.
xii. Patients who smoke (≥ 10 cigarettes/day or equivalent) or consume tobacco products (≥ 4 chews of any form/day).
xiii. Female patient who is pregnant, lactating or likely to become pregnant or have a positive pregnancy test at screening or during check-in.
xiv. Difficulty in coming for follow up.
xv. Patients who have participated in another clinical study for at least 90 days prior to first dosing.
xvi. Blood donation within 90 days prior to first dosing.
xvii. Patients who have:
Systolic blood pressure <90 mm of Hg or >140 mm of Hg
Diastolic blood pressure <60 mm of Hg or >90 mm of Hg
Minor deviations (2-4mm Hg) at check-in may be acceptable at the discretion of the investigator.
Radial pulse rate <60/min. or >100/min.
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Method of Generating Random Sequence
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Permuted block randomization, fixed |
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Method of Concealment
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Centralized |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| To assess the bioequivalence between Test product (A) and Reference product (B) in Patients requiring Amphotericin B Liposome for Injection under fed condition. |
at-48.000 [on Day 03] and at -24.000 [Day 04] and 0.000 [on Day 05] hrs within a period of 5 minutes prior to start of infusion (at same time from each dose) at respective days.Post-dose blood samples (3 mL each) will be collected at 1.000, 1.333, 1.667, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 6.000, 8.000, 12.000, 18.000 and 24.000 hours after the start of infusion [on Day 05] |
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Secondary Outcome
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| Outcome |
TimePoints |
| To monitor the safety of Test product (A) and Reference product (B) in Patients requiring Amphotericin B Liposome for Injection |
throughout study |
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Target Sample Size
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Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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N/A |
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Date of First Enrollment (India)
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20/03/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="1"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
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Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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None yet. |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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This study is a randomized, open label, two treatment, one period, multiple dose, steady-state, parallel, bioequivalence study of Amphotericin b liposome for injection 50 mg / vial of sun pharmaceutical industries limited and Ambisome (amphotericin b) liposome for injection 50 mg / vial of astellas pharma in 48 (24+24) patients under fed condition |