REF/2013/04/004879
CTRI Website URL - http://ctri.nic.in
Clinical Trial Details (PDF Generation Date :- Sat, 01 Oct 2016 10:28:44 GMT)
CTRI Number
CTRI/2014/12/005245 [Registered on: 03/12/2014] - Trial Registered Retrospectively
Last Modified On
11/01/2016
Post Graduate Thesis No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Placebo Controlled Trial
Public Title of Study
Clinical study to evaluate the Safety, Tolerability and Pharmacokinetics of Tapentadol Nasal Spray
in Healthy Human Volunteers
Scientific Title of
Study
A Mono centric, Double Blind, Randomized, Placebo controlled Sequential Phase-I Study to
Evaluate Safety, Tolerability and Pharmacokinetics of Nasal Spray of Tapentadol HCl (Torrent
Pharmaceuticals Ltd., India) following Single and Multiple Ascending Doses in Healthy Human
Volunteers.
Secondary IDs if Any
Secondary ID
Identifier
PK-12-031 Version No:3 Date:27/12/2013
Protocol Number
Details of Principal
Investigator or overall
Name
Trial Coordinator
Designation
(multi-center study)
Affiliation
Details Contact
Person (Scientific
Query)
Details of Principal Investigator
Dr Sushil Kumar Anand
Assistant General Manager
Torrent Pharmaceuticals Ltd
Address
Bio-Evaluation Centre, Torrent Pharmaceuticals Ltd. Village Bhat,
Gandhinagar PIN-382428, Gujarat, India
Gandhinagar
GUJARAT
382428
India
Phone
9824389855
Fax
917923969135
Email
sushilkumaranand@torrentpharma.com
Details Contact Person (Scientific Query)
Name
Dr Shivani Acharya
Designation
Assistant General Manager
Affiliation
Torrent Pharmaceuticals Ltd
Address
Torrent Pharmaceuticals Ltd. Village Bhat, Gandhinagar
PIN-382428, Gujarat, India
Gandhinagar
GUJARAT
382428
India
Phone
Details Contact
Person (Public Query)
Fax
917923969135
Email
shivaniacharya@torrentpharma.com
Details Contact Person (Public Query)
Name
Dr Shivani Acharya
Designation
Assistant General Manager
Affiliation
Torrent Pharmaceuticals Ltd
Address
Torrent Pharmaceuticals Ltd. Village Bhat, Gandhinagar
PIN-382428, Gujarat, India
Gandhinagar
GUJARAT
382428
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REF/2013/04/004879
CTRI Website URL - http://ctri.nic.in
India
Phone
Source of Monetary or
Material Support
Fax
917923969135
Email
shivaniacharya@torrentpharma.com
Source of Monetary or Material Support
> Torrent Pharmaceuticals Ltd
Primary Sponsor
Primary Sponsor Details
Name
Torrent Pharmaceuticals Ltd
Address
Torrent Research Centre, Village Bhat, Dist. Gandhinagar,
PIN-382428, Gujarat,India.
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary
Sponsor
Name
Address
NIL
NIL
Countries of
Recruitment
List of Countries
Sites of Study
Name of Principal
Investigator
India
Site Address
Phone/Fax/Email
Dr Sushil Kumar Anand Bio-Evaluation Centre
Torrent
Pharmaceuticals Ltd.,
Village Bhat,
Gandhinagar 382428,
Gujarat, India
Gandhinagar
GUJARAT
9824389855
917923969135
sushilkumaranand@torr
entpharma.com
Name of Committee
Date of Approval
Is Independent Ethics
Committee?
Sangini Hospital Ethics Approved
Committee
08/07/2014
No
Sangini Hospital Ethics Approved
Committee
07/11/2015
No
Regulatory Clearance
Status from DCGI
Status
Date
Approved/Obtained
02/09/2013
Health Condition /
Problems Studied
Health Type
Condition
Healthy Human Volunteers
To study the Safety,Tolerabilty and
Pharmacokinetics of Tapentadol Nasal Spray
Intervention /
Comparator Agent
Type
Name
Details
Comparator Agent
Placebo Nasal Spray
Route of Administration:Nasal
Intervention
Tapentadol Nasal Spray
Route of Administration:Nasal.
Single and multiple dose
ascending study
Details of Ethics
Committee
Name of Site
Approval Status
Inclusion Criteria
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Male
Details
1. Sex: male
2. Age: 18 - 45 years (inclusive both)
3. Volunteer with BMI of 18.5-30 kg/m2 (inclusive both) with
minimum of 50 kg weight.
4. Volunteer willing to provide written informed consent.
5. Non-smokers or smoker who smokes less than 10 cigarettes per
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REF/2013/04/004879
CTRI Website URL - http://ctri.nic.in
day.
5Non-smokers or smoker who smokes less than 10 cigarettes per
day.
Exclusion Criteria
Exclusion Criteria
Details
1. Inability to communicate or co-operate.
2. Volunteers suffering from any chronic illness such as asthma etc.
3. History of pre-existing bleeding disorder.
4. Clinically relevant abnormalities in the results of the laboratory
screening evaluation.
5. Clinically significant abnormal ECG or Chest X-ray.
6. HIV, HCV, HbsAg positive volunteers.
7. History of significant blood loss due to any reason, including blood
donation in the past 3 months.
8. Participation in any study within past 3 months.
9. History of alcohol or drug abuse.
10. History of consumption of prescribed medication since last 14
days or OTC medication/ herbal remedies since last 7 days before
beginning of the study.
11. Positive to Breath alcohol test.
12. Opiate, tetra hydrocannabinol, amphetamine, barbiturates,
benzodiazepines, Cocaine positive volunteers based on urine test.
13. Systolic blood pressure less than 100 mmHg or more than 139
mmHg and diastolic blood pressure less than 60 mmHg or more than
89 mmHg.
14. Persistent pulse rate more than 100/minute.
15. Oral temperature more than 98.9°F.
16. Respiratory rate more than 20/minute
17. History of any drug allergy.
18. History of kidney or liver dysfunction within last 6 months.
19. Volunteers suffering from any psychiatric (acute or chronic)
disorder.
20. Existence of any surgical or medical condition, which, in the
judgment of the Chief Investigator and/or clinical
investigator/physician, might interfere with the absorption,
distribution, metabolism or excretion of the drug or likely to
compromise the safety of volunteers.
21. H/O current upper respiratory tract infection or other respiratory
tract condition that could interfere with the absorption of the nasal
spray.
22. H/O use of any medication by nasal route within past 72 hours of
the study.
23. H/O tobacco sniffing.
24. H/O any chronic nasal conditions i.e., atrophic rhinitis, nasal
polyp etc which can interfere with the absorption of the drug.
Method of Generating Computer generated randomization
Random Sequence
Method of
Concealment
Pharmacy-controlled Randomization
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
Timepoints
To evaluate the safety and tolerability of
NA
ascending single and multiple doses of
Tapentadol HCl administered as a nasal spray in
healthy volunteers.
Secondary Outcome
Outcome
To study the pharmacokinetics of Tapentadol
Timepoints
NA
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REF/2013/04/004879
CTRI Website URL - http://ctri.nic.in
HCl nasal spray in healthy volunteers.
Target Sample Size
Total Sample Size=16
Sample Size from India=16
Phase of Trial
Phase 1
Date of First
Enrollment (India)
23/07/2014
Date of First
Enrollment (Global)
23/07/2014
Estimated Duration of Years=0
Trial
Months=3
Days=0
Recruitment Status of Not Applicable
Trial (Global)
Recruitment Status of Open to Recruitment
Trial (India)
Publication Details
NA
Brief Summary
Single ascending dose study proposed schedule:
Dose Level 1: 23/07/2014
Dose Level 2: 13/08/2014
Dose Level 3: 25/04/2015
Dose Level 4: 26/05/2015
Dose Level 5: 25/06/2015
Dose Level 6: 27/07/2015
Multiple ascending dose study proposed schedule: 15/09/2015
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