| CTRI Number |
CTRI/2024/10/075391 [Registered on: 16/10/2024] Trial Registered Prospectively |
| Last Modified On: |
23/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
NA |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Bioequivalence study of Venetoclax Tablets 100 mg in healthy adult human subjects under fed conditions. |
|
Scientific Title of Study
|
An Open-label, balanced, randomized, two-treatment, two period, two-sequence, single dose, crossover, oral bioequivalence study of CLEXZA (Venetoclax) Tablets 100 mg by M/s. Azista Bhutan Healthcare Limited with Venclyxto 100 mg film-coated tablets (Venetoclax) of AbbVie Deutschland GmbH & Co. Germany in healthy adult human subjects under fed conditions. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBio/019/0324, Version: 00, Dated: 20 Mar 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ankita Das |
| Designation |
Principal Investigator |
| Affiliation |
ICBio Clinical Research Private limited |
| Address |
Investigator Room No: 01, Ground floor, Clinical department, No. 2, ICBio tower II, Devi Circle, Yelahanka Main Road,
Chikkabetahalli, Vidyaranyapura
Bangalore
KARNATAKA
560097
India |
| Phone |
8069423000 |
| Fax |
|
| Email |
headcl@icbiocro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harish S |
| Designation |
Director |
| Affiliation |
ICBio Clinical Research Private limited |
| Address |
No. 2, ICBio tower II, Devi Circle, Yelahanka Main Road, Chikkabetahalli, Vidyaranyapura
Bangalore
KARNATAKA
560097
India |
| Phone |
09900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harish S |
| Designation |
Director |
| Affiliation |
ICBio Clinical Research Private limited |
| Address |
No. 2, ICBio tower II, Devi Circle, Yelahanka Main Road, Chikkabetahalli, Vidyaranyapura
Bangalore
KARNATAKA
560097
India |
| Phone |
09900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
| ICBio Clinical Research Private limited, No. 2, ICBio tower II, Devi Circle, Yelahanka Main Road,
Chikkabetahalli, Vidyaranyapura,
Bangalore-560097 India
|
|
|
Primary Sponsor
|
| Name |
M/s. Azista Bhutan Healthcare Limited |
| Address |
Plot no:M-22 &M-25, Motanga Industrial Park, Samdrup Jongkhar, Bhutan. |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ankita Das |
ICBio Clinical Research Private limited |
No. 2, ICBio Tower-II, Devi Circle, chikkabettahalli, Yelahanka Main Road, vidyaranapura
Bangalore
KARNATAKA |
8069423000
headcl@icbiocro.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fed condition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CLEXZA (Venetoclax) Tablets 100
mg |
Name of the drug: CLEXZA (Venetoclax) Tablets 100 mg, Route of administration: Oral, Frequency: single oral dose, Study duration:13 days |
| Comparator Agent |
Venclyxto 100 mg film-coated tablets (Venetoclax) |
Name of the drug: Venclyxto 100 mg film-coated tablets (Venetoclax), Route of administration: Oral, Frequency: single oral dose, Study duration:13 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of the study.
2. Willing to be available for the entire study period and to comply with protocol requirements.
3. Normal, healthy, adult, human subject of 18-55 years (both inclusive) of age.
4. Body mass index in the range of 18.5 – 30.0 kg/m2 both inclusive.
5. Healthy volunteers who are clinically non anemic will be included as per the discretion
of PI/CI/Physician. |
|
| ExclusionCriteria |
| Details |
1. Any medical or surgical condition, which might significantly interfere with the functioning of the gastrointestinal tract or blood–forming organs.
2. History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools
anytime in the past along with chronic lymphocytic leukemia and small cell lymphocytic leukemia.
3. History of severe infection or major surgery in the past 6 months.
4. History of Minor surgery or fracture within the past 3 months.
5. Significant history or current evidence of malignancy or chronic - infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, immunological or psychiatric diseases, or organ dysfunction. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate Pharmacokinetics parameters: Cmax and AUC0-t |
From Day 01 to Day 13 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate Pharmacokinetics parameters: AUC0-∞, Tmax, AUC_%Extrap_obs, λz and t1/2 |
From Day 01 to Day 13 |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/11/2024 |
| 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 |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="13" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
STUDY TITLE:An Open-label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study of CLEXZA (Venetoclax) Tablets 100 mg by M/s. Azista Bhutan Healthcare Limited with Venclyxto 100 mg film-coated tablets (Venetoclax) of AbbVie Deutschland GmbH & Co. Germany in healthy adult human subjects under fed conditions.
OBJECTIVES:
Primary objective: To compare the rate and extent of absorption of CLEXZA (Venetoclax) Tablets 100 mg by M/s. Azista Bhutan Healthcare Limited with Venclyxto 100 mg film-coated tablets (Venetoclax) of AbbVie Deutschland GmbH & Co. Germany in healthy adult human subjects under fed conditions.
Secondary objective: To monitor the safety and tolerability of the study subjects after administration of Venetoclax Tablets 100 mg in healthy, adult, human subjects under fed condition.
Number of subjects: Thirty-two (32) subjects Duration of clinical study: 13 days |