CTRI/2024/08/073151 [Registered on: 30/08/2024] Trial Registered Prospectively
Last Modified On:
29/08/2024
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Crossover Trial
Public Title of Study
Bioequivalence study of Gabapentin and Nortriptyline hydrochloride tablets of Intas pharmaceuticals Ltd, India to GABATOR NT in normal, healthy, adult, human subjects
Scientific Title of Study
An open label, balanced, randomized, two-treatment, two-period, two-sequence, crossover, single oral dose, bioequivalence study of Gabapentin and Nortriptyline hydrochloride tablets of Intas pharmaceuticals Ltd, India with GABATOR NT (gabapentin and nortriptyline tablets) 200 mg+ 10 mg of Torrent pharmaceuticals Ltd, Indrad, Dist. Mehsana, India in normal, healthy, adult, human subjects under fasting condition
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
Protocol no.: 0297-22,version-01,Date : 26 June 2023
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Jogesh Mahajan
Designation
Senior Vice President
Affiliation
Lambda Therapeutic Research Ltd
Address
Lambda House, Department of Clinical Research, Room No. NA, Plot No. 38, Survey no. 388,Near Silver Oak Club, S. G. Highway,
Gota Ahmadabad
Ahmadabad GUJARAT 382481 India
Phone
07940202214
Fax
07940202021
Email
jogeshmahajan@lambda-cro.com
Details of Contact Person Scientific Query
Name
Dr Dwarkesh Oswal
Designation
Sr. Manager
Affiliation
Lambda Therapeutic Research Ltd
Address
Lambda House, Plot No. 38, Survey no. 388,Near Silver Oak Club, S. G. Highway, Gota Ahmadabad
Ahmadabad GUJARAT 382481 India
Phone
07940202281
Fax
07940202021
Email
dwarkeshroswal@lambda-cro.com
Details of Contact Person Public Query
Name
Dr Jogesh Mahajan
Designation
Senior Vice President
Affiliation
Lambda Therapeutic Research Ltd
Address
Lambda House, Plot No. 38, Survey no. 388,Near Silver Oak Club, S. G. Highway, Gota Ahmadabad
Ahmadabad GUJARAT 382481 India
Phone
07940202214
Fax
07940202021
Email
jogeshmahajan@lambda-cro.com
Source of Monetary or Material Support
Intas Pharmaceuticals Limited Corporate House, Near Sola Bridge, S.G. Highway, Thaltej,
Ahmedabad - 380054, Gujarat, India
Primary Sponsor
Name
Intas Pharmaceuticals Ltd
Address
Corporate House, Near Sola Bridge, S.G. Highway, Thaltej,
Ahmedabad - 380054, Gujarat, India
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
NA
NA
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Dwarkesh Oswal
Lambda Therapeutic Research Ltd
Plot No. 38, Survey no. 388, Lambda house, ,Near Silver Oak Club, S. G. Highway, Gota, Ahmadabad GUJARAT
Gabapentin and Nortriptyline Hydrochloride Tablets 200mg +10mg
Route of administration-Oral Dose strength-200 & 10mg
Intervention
GABATOR NT (Gabapentin and Nortriptyline tablets) 200 mg+ 10 mg
Route of administration-Oral
Dose strength-200 & 10mg
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Both
Details
a. Non-smoker, Normal, Healthy adult human volunteers between 18 to 45 years of age (both
inclusive).
b. Having a Body Mass Index (BMI) between 18.5 to 29.9 (both inclusive), calculated as weight in
kg I height in m2
•
c. Not having any significant diseases or clinically significant abnormal findings during screening,
medical history, clinical examination, laboratory evaluations, 12-lead ECG and X-ray chest
(postero-anterior view) recordings.
d. Able to understand and comply with the study procedures, in the opinion of the investigator.
e. Able to give voluntary written informed consent for participation in the trial.
f. In case of female subjects:
I. Surgically sterilized at least 6 months prior to study participation.
Or
If of child-bearing potential is willing to use a suitable and effective double barrier
contraceptive method or intra uterine device during the study.
And
ii. Serum pregnancy test must be negative
ExclusionCriteria
Details
a) Known hypersensitivity or idiosyncratic reaction to Gabapentin or Nortriptyline or to any of its
excipients or any drug or any substance.
b) History or presence of any disease or condition which might compromise the haemopoietic,
renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological,
dermatological, gastrointestinal disorder including bleeding or any other body system disorders.
c) Ingestion or use of any medication [prescribed & over the counter (OTC) medication including
herbal remedies and and CNS depressants including opioids, sympathomimetic agents such as
adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine.)
and Cytochrome P450 inhibitors (Cimetidine, methylphenidate)] at any time within 14 days prior
to dosing of period-I and any vaccine (including COVID-19 vaccine) from 14 days prior to
dosing of period-I. In any such case subject selection will be at the discretion of the Principal
Investigator.
d) Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAID
induced miicaria.
e) A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more
than 14 standard drinks per week for men and more than 7 standard drinks per week for women
(A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40 % distilled
spirits, such as rum, whisky, brandy etc) or consumption of alcohol or alcoholic products within
48 hours prior to receiving study medicine in period-I.
f) Smokers or who have smoked within last 06 months prior to start of the study.
g) The presence of clinically significant abnormal laboratory values during screening.
h) Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug
scans.
i) QTc interval more than 450 msec on ECG measurement at the time of screening.
j) Subjects with suicidal behavior at the time of screening
k) History or presence of seizure or psychiatric disorders.
I) A history of difficulty with donating blood.
m) Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose of study
medication.
n) Receipt of an investigational medicinal product or participation in a drug research study within a
period of 90 days prior to the first dose of study medication If investigational medicinal product is received within 90 days where there is no blood loss
except safety lab testing, subject can be included considering 10 half-lives duration of
investigational medicinal product received.
o) A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
p) A positive test result for HIV (1 &/or 2) antibody.
q) Consumption of Grapefruits or Grapefruit products within a period of 72 hours prior to receiving
the study drug in period-I.
r) Difficulty in swallowing solids oral dosage forms like tablets or capsules.
s) An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the
study drug in period-I. In any such case subject selection will be at the discretion of the Principal
Investigator.
t) Nursing mothers (for female subjects)
Total Sample Size="60" Sample Size from India="60" 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)
09/09/2024
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="1" Days="0"
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
AN OPEN LABEL, BALANCED, RANDOMIZED, TWO-TREATMENT, TWO-PERIOD, TWOSEQUENCE,
CROSSOVER, SINGLE ORAL DOSE, BIOEQUIV ALENCE STUDY OF
GABAPENTIN AND NORTRIPTYLINE HYDROCHLORIDE TABLETS OF INT AS
PHARMACEUTICALS LTD, INDIA WITH GABA TOR NT (GABAPENTIN AND
NORTRIPTYLINE TABLETS) 200 MG+ 10 MG OF TORRENT PHARMACEUTICALS LTD,
INDRAD, DIST. MEHSANA, INDIA IN NORMAL, HEALTHY, ADULT, HUMAN SUBJECTS