| CTRI Number |
CTRI/2022/05/042428 [Registered on: 10/05/2022] Trial Registered Prospectively |
| Last Modified On: |
07/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
bioequivalence study of FDC of Azelnidipine 8 mg and Telmisartan 40 mg tablet of Signature Phytochemical Industries |
|
Scientific Title of Study
|
An Open label, balanced, randomized, two-treatment, twoperiod,
two-sequence, single oral dose, crossover,
bioequivalence study of FDC of Azelnidipine 8 mg +
Telmisartan 40 mg tablet of Signature Phytochemical
Industries with Uniaz T 40mg tablet (Azelnidipine 8 mg +
Telmisartan 40 mg) of Synokem Pharmaceuticals Ltd., in
healthy adult human subjects under fasting conditions. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBio/024/0721, version 01 dated : 10 Mar 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priya R |
| Designation |
Principal Investigator |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
#16 & 18, ICBio Tower, Chikkabettahalli,
Yelahanka Main Road,
Vidyaranyapura,
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
pi.mail@icbiocro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harish S |
| Designation |
Director Operations |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
#16&18, ICBio Tower, Chikkabettahalli,
Yelahanka Main Road,
Vidyaranyapura,
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harish S |
| Designation |
Director Operations |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
#16&18, ICBio Tower, Chikkabettahalli,
Yelahanka Main Road,
Vidyaranyapura,
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
| Signature Phytochemical Industries |
|
|
Primary Sponsor
|
| Name |
Signature Phytochemical Industries |
| Address |
122 MI, Selaqui Industrial Area,
Dehradun (UK)-248 011
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Priya R |
ICBio Clinical Research Pvt. Ltd. |
#16 & 18 ICBio Tower, Yelahanka Main Road,
Chikkabetahalli, Vidyaranyapura
Bangalore
KARNATAKA |
9900111997
pi.mail@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 |
Healthy subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FDC of Azelnidipine 8 mg and Telmisartan 40 mg tablet |
dose: Azelnidipine 8 mg and Telmisartan 40 mg,
frequency: Single dose one time during the study,
route of administration: oral,
duration: period I, period II. |
| Comparator Agent |
Uniaz T 40mg tablet |
dose: Uniaz T 40mg tablet (Azelnidipine 8 mg +
Telmisartan 40 mg),
frequency: Single dose one time during the study,
route of administration: oral, duration: period I, period II. |
|
|
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 – 30 kg/m2 (both inclusive).
5.Normal haemoglobin between 12.5 to 17.5 grams per deciliter (g/dL) for men and 12 to 16 g/dL for female.
|
|
| ExclusionCriteria |
| Details |
1.Found positive (+ve) on rapid test for COVID-19 during screening.
2.Haemoglobin level less than 12.5 grams per deciliter for men and 12 grams per deciliter for women.
3.Any medical or surgical conditions, which might significantly interfere with the functioning of the gastrointestinal tract and blood–forming organs.
4.History of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cmax, AUC0-t and AUC0-∞ |
From day 1 and day 19 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Tmax , AUC_%Extrap_obs, λz and t1/2 |
From day 1 and day 19 |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
Final Enrollment numbers achieved (Total)= "28"
Final Enrollment numbers achieved (India)="28" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/05/2022 |
| Date of Study Completion (India) |
29/05/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="19" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
An
Open label, balanced, randomized, two-treatment, two-period, two-sequence,
single oral dose, crossover, bioequivalence study of FDC of Azelnidipine 8 mg + Telmisartan 40
mg tablet of Signature Phytochemical Industries with
Uniaz T 40mg tablet (Azelnidipine 8 mg + Telmisartan 40
mg) of Synokem Pharmaceuticals Ltd.,
in healthy adult human subjects under fasting
conditions.Primary
objective:
To compare bioequivalence
of FDC of Azelnidipine 8 mg + Telmisartan
40 mg tablet of Signature Phytochemical Industries with Uniaz T 40mg tablet (Azelnidipine
8 mg + Telmisartan 40 mg) of
Synokem
Pharmaceuticals Ltd., in healthy adult human subjects under fasting
conditions.
Secondary
objective:
To monitor and assess
safety and tolerability of the investigational products in healthy adult human
subjects under fasting condition. |