| CTRI Number |
CTRI/2020/03/024009 [Registered on: 17/03/2020] Trial Registered Prospectively |
| Last Modified On: |
06/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A study to evaluate effect of single oral dose of SDN-118 Capsules in healthy adult Human subjects |
|
Scientific Title of Study
|
A Randomized, Open-Label, Three-period, Three-Way, Crossover Study to Evaluate Pharmacokinetics, Safety and Tolerability of Single Oral Dose of Amitriptyline Hydrochloride Capsules, 25 mg in Healthy, Adult Human Subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SDN-118-18-17 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mudgal Kothekar MD |
| Designation |
Associate Vice President Clinical Development |
| Affiliation |
Sun Pharma Advanced Research Company Limited |
| Address |
17/B, Mahal Industrial Estate, Mahakali Caves Road, Andheri East.
Mumbai
MAHARASHTRA
400093
India |
| Phone |
912266455645 |
| Fax |
|
| Email |
Clinical.Trials@sparcmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mudgal Kothekar MD |
| Designation |
Associate Vice President Clinical Development |
| Affiliation |
Sun Pharma Advanced Research Company Limited |
| Address |
17/B, Mahal Industrial Estate, Mahakali Caves Road, Andheri East.
MAHARASHTRA
400093
India |
| Phone |
912266455645 |
| Fax |
|
| Email |
Clinical.Trials@sparcmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mudgal Kothekar MD |
| Designation |
Associate Vice President Clinical Development |
| Affiliation |
Sun Pharma Advanced Research Company Limited |
| Address |
17/B, Mahal Industrial Estate, Mahakali Caves Road, Andheri East.
MAHARASHTRA
400093
India |
| Phone |
912266455645 |
| Fax |
|
| Email |
Clinical.Trials@sparcmail.com |
|
|
Source of Monetary or Material Support
|
| Sun Pharma Advanced Research Company Limited |
|
|
Primary Sponsor
|
| Name |
Sun Pharma Advanced Research Company Limited |
| Address |
17 B, Mahal Industrial Estate, Mahakali Caves Road, Andheri (East),
Mumbai 400093 |
| 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 Nil Desai MD |
Cliantha Research Limited |
Sigma-1 Corporate,
Behind Rajpath Club,
Opposite Mann Party Plot,
Sarkhej Gandhinagar Highway,
Bodakdev,
380054,
India
Ahmadabad
GUJARAT |
91-79-66135601
91-79-66135602
nhdesai@cliantha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sangini Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Treatment A : Amitriptyline Hydrochloride, 25 mg |
Dose
Frequency of administration: single oral dose;
route of administration: Oral |
| Intervention |
Treatment B: Amitriptyline Hydrochloride, 25 mg |
Dose
Frequency of administration: single oral dose;
route of administration: Oral |
| Intervention |
Treatment C: Amitriptyline Hydrochloride, 25 mg |
Dose
Frequency of administration: single oral dose;
route of administration: Oral |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy, adult males and females aged 18 to 45 years, inclusive, at screening
2. Body mass index (BMI) greater than equal to 18 to less than equal to 32 kg/m2 and total body weight greater than 50 kg (110 lbs) at screening.
3. Subject is able and willing to provide written informed consent and to complete all study procedures
4. Females of childbearing potential must not be pregnant (as confirmed by a negative serum pregnancy test) or lactating.
5. Women of childbearing potential must agree to use contraception (barrier method) throughout the study.
6. Male subjects must agree to use an acceptable form of birth control to prevent pregnancy in the female partner and must agree not to donate the sperm throughout the duration of the study.
7. Medically healthy on the basis of medical history and physical examination (including but not limited to an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), as determined by the Investigator.
8. Subjects not having clinically significant history or signs of significant hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric disease, or active sexually transmitted disease.
9. Medically healthy based on the absence of clinically significant abnormal vital sign measurements, clinical laboratory test results (especially tests for renal and hepatic function) or ECG parameters (including sick sinus syndrome, second- or third- degree atrial ventricular block, cardiogenic shock and decompensated heart failure), as determined by the Investigator.
10. The subject must be willing and able to comply with study restrictions and able to remain at the clinic for the required duration during the study, and is willing to return to the clinic for the follow-up evaluation as specified in this protocol. |
|
| ExclusionCriteria |
| Details |
1. History of allergic reaction or a severe adverse reaction to amitriptyline or any other antidepressants or related excipients
2. History of alcohol or substance abuse within the past 12 months (DSM-V definition of alcohol or substance abuse)
3. History of depression, seizure (including febrile seizure), syncope or loss of consciousness due to head trauma
4. History or risk of serotonin syndrome
5. History of acute myocardial infarction within 1 year from day of screening
6. History of seizures within 1 year from day of screening
7. History of benign prostate hypertrophy
8. History of angle-closure glaucoma
9. Subjects with hyperthyroidism or taking thyroid medication
10. History of suicidal ideation as assessed by subject medical history
11. Use of concomitant prescription or non-prescription drugs, dietary supplements, or herbal supplements within 14 days before check-in in Period 1
12. History of difficulty in swallowing.
13. Subjects who donated greater than equal to 500 mL of blood within 56 days prior to check-in in period 1 or greater than equal to 50 mL and less than equal to 499 mL of blood within 30 days prior to check-in in Period 1
14. Subjects who have had a tattoo or body piercing within 30 days prior to check-in in Period 1
15. ECG results indicating QTc greater than 450 msec (male) or greater than 470 msec (female) or QRS greater than 120 msec. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pharmacokinetics of amitriptyline |
over 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| pharmacokinetics of amitriptyline |
over 24 hours |
| pharmacokinetics of nortriptyline |
over 24 hours |
Incidence, frequency, and intensity of spontaneously reported or observed adverse events (AEs)
|
Till study completion |
Vital signs (blood pressure, respiratory rate, heart rate, and body temperature)
|
before and after dosing |
| Electrocardiograms (ECGs) |
Before and after dosing |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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
|
Phase 1 |
Date of First Enrollment (India)
Modification(s)
|
26/10/2020 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is designed to evaluate the pharmacokinetics of amitriptyline and nortriptyline following a single dose administration of the reference and the test product. |