| CTRI Number |
CTRI/2020/01/022665 [Registered on: 09/01/2020] Trial Registered Prospectively |
| Last Modified On: |
10/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
Comparative pharmacokinetic study under fasting and fed condition |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A study of CPL-2009-0031 140mg Tablets of Cadila Pharmaceuticals with JANUVIA 100mg Tablets of MSD Pharmaceuticals in healthy subjects. |
|
Scientific Title of Study
|
A randomized, open-label, two-treatment, four-period, two-sequence, single-dose, balanced, crossover, comparative pharmacokinetic study of CPL20090031 Tablets 140mg of Cadila Pharmaceuticals Ltd, India with JANUVIA (Sitagliptin) Tablets 100mg of MSD Pharmaceuticals Limited, India in healthy, adult human subjects under fasting and fed condition. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 18-028, version no. 01, 23.10.18 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjay Patel |
| Designation |
Head – Bioequivalence |
| Affiliation |
Cadila Pharmaceuticals Ltd. |
| Address |
Department of Clinical Pharmacology,
Research and Development Centre,
Cadila Pharmaceuticals Ltd.,
1389,Trasad Road,
Dholka-382225,
Ahmedabad,Gujarat,
India.
Ahmadabad
GUJARAT
382225
India |
| Phone |
91-9825603307 |
| Fax |
|
| Email |
sanjay.p@cadilapharma.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Patel |
| Designation |
Head – Bioequivalence |
| Affiliation |
Cadila Pharmaceuticals Ltd. |
| Address |
Department of Clinical Pharmacology,
Research and Development Centre,
Cadila Pharmaceuticals Ltd.,
1389,Trasad Road,
Dholka-382225,
Ahmedabad,Gujarat,
India.
Ahmadabad
GUJARAT
382225
India |
| Phone |
91-9825603307 |
| Fax |
|
| Email |
sanjay.p@cadilapharma.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Patel |
| Designation |
Head – Bioequivalence |
| Affiliation |
Cadila Pharmaceuticals Ltd. |
| Address |
Department of Clinical Pharmacology,
Research and Development Centre,
Cadila Pharmaceuticals Ltd.,
1389,Trasad Road,
Dholka-382225,
Ahmedabad,Gujarat,
India.
1389,Trasad Road,
Dholka-382225,
Ahmedabad,Gujarat,
India.
GUJARAT
382225
India |
| Phone |
91-9825603307 |
| Fax |
|
| Email |
sanjay.p@cadilapharma.co.in |
|
|
Source of Monetary or Material Support
|
| Cadila Pharmaceuticals Ltd.,
1389,Trasad Road,
Dholka-382225,
Ahmedabad,Gujarat,
India. |
|
|
Primary Sponsor
|
| Name |
Cadila Pharmaceuticals Limited |
| Address |
1389, Trasad Road,
Dholka -382225
Ahmedabad, Gujarat, India. |
| 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 Sanjay Patel |
Cadila Pharmaceutical Ltd. |
Ground floor, Clinical Pharmacology and Pharmacokinetic Department,
Research and Development, CRO Division,
1389, Trasad Road, Dholka - 382225. Ahmedabad.
Gujarat. India.
Ahmadabad
GUJARAT |
91-9825603307
sanjay.p@cadilapharma.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Riddhi Medical Nursing Home |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Adult Volunteer |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CPL-2009-0031 140 mg Tablets |
Single dose duration, once Oral tablet
containing 140 mg of
CPL-2009-0031 of Cadila Pharmaceutical Ltd., India |
| Comparator Agent |
Sitagliptin 100 mg Tablets |
Single dose duration, once Oral tablet containing 100 mg of Sitagliptin of MSD Pharmaceuticals Limited, India. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy, adult human subject aged from 18 to 45 years (inclusive both).
2.Subject’s Body Mass Index (BMI) within normal limit of 18.50-24.90 kg/m2 (inclusive both).
3.Willingness to sign statements of written informed consent form (for screening & study related procedures).
4.No contraindications with the study medication with any previous medical or surgical history.
5.Willingness to undergo pre- and post-study physical examinations and laboratory investigations.
6.Normal general physical examination.
7.Normal ECG finding and vital signs, or abnormalities, which the clinical investigator does not consider a disqualification for participation in the study.
8.Investigations with blood sample of the subjects, shows the presence of values which are within acceptable range (as per Annexure-I)
9.Those laboratory values outside acceptable range can be considered clinically insignificant as per PI sole discretion.
10.Availability of subject for the entire study period and willingness to adhere to protocol.
11.Non-smokers.
12.Female counselled for barrier method of contraception
|
|
| ExclusionCriteria |
| Details |
1.Institutionalized volunteers.
2.Subjects incapable of understanding the informed consent process/ procedure.
3.Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study, or limit the ability to comply with protocol requirements.
4.Resting heart rate of >100 beats/min or < 60 beats/min on the screening day.
5.History of hypotensive episodes, or systolic blood pressure reading of < 100 mmHg or a diastolic reading of < 60 mmHg at time of general Physical examination.
6.History of hypertension, or systolic blood pressure reading of > 140 mmHg or a diastolic reading > 90 mmHg at time of general Physical examination.
7.The subject has any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
8.Subject who have taken any enzymes modifying drugs within the past four weeks prior to start of clinical period.
9.Subject who have taken any prescribed medications beginning two weeks prior to and OTC medications beginning one week prior to first dosing of study.
10.The subject with known drug hypersensitivity or idiosyncratic reaction to Sitagliptin, or any related drug or heparin.
11.Subjects who are taking terfenadine, astemizole, cisapride, pimozide, ergotamine or dihydroergotamine.
12.History of Hepatotoxicity, QT Prolongation, arrhythmia and Clostridium difficile associated Diarrhea.
13.History of myasthenia gravis.
14.The subject with known history of clinically significant psychiatric or medical diseases will be excluded from the study.
15.History of or current alcohol abuse (>600 mL weekly) or history of exposure to other substance of abuse.
16.Investigations with blood samples of the subject shows presence of disease marker of HIV 1 and 2, Hepatitis B & C viruses.
17.Positive test for urinary screen testing of drugs of abuse (Amphetamines, Morphine, Benzodiazepines, Marijuana, Cocaine and Barbiturate).
18.Subject found positive for alcohol breath test.
19.Investigations with blood sample of the subjects, shows the presence of values which are clinically significantly different from normal reference range.
20.Investigations with urine sample of the subject shows clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC, epithelial cells, glucose and protein (unless the clinical investigator considers the deviation to be irrelevant for the purpose of the study).
21.Subject who participated in any other clinical investigation using experimental drug or had bleed more than 300 ml in the past 3 months.
22.Xanthine-containing food or beverages (tea, coffee, chocolates, soft drinks like cola etc.) within 24 hours prior to the dosing of each period or alcoholic products consumption within 48 hours prior to the dosing of each period.
23.Subjects who have consumed “Grapefruit†or its juice within 72 hours prior to dosing of each period.
24.Subject without adequate venous access in their left or right arm to allow collection of all samples via venous cannula in each period of the study.
25.X-ray chest finding suggesting of any abnormality/ies like cardiomegalia, pneumonia etc.
26.Subject with a pre-existing condition interfering with normal gastrointestinal anatomy or motility, hepatic and /or renal function, that could interfere with the absorption, metabolism, and /or excretion of the study drugs.
27.Subjects with a history of cholecystectomy.
28.Females who are falling in menstruation period during study.
29.Females who are found positive in Urinary Pregnancy Test.
30.Females who are lactating their children.
31.Females who are using any type of hormonal contraceptives. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the comparative pharmacokinetic of CPL-2009-0031 Tablets 140mg of Cadila Pharmaceuticals Ltd., India with JANUVIA (Sitagliptin) Tablets 100mg of MSD Pharmaceuticals Limited, India in healthy, adult human subjects under fasting and fed condition. |
Pharmacokinetic blood sample collection at pre-dose (0.00) and 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 48.00 and 72.00 hours post-dose. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate safety parameters, including adverse events and clinical laboratory tests. |
Safety assessment till end of study |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
Final Enrollment numbers achieved (Total)= "16"
Final Enrollment numbers achieved (India)="16" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/01/2020 |
| Date of Study Completion (India) |
03/02/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A randomized,
open-label, two-treatment, four-period, two-sequence, single-dose, crossover comparative
pharmacokinetic study in 16 healthy, adult, human subjects of 18-45 years for comparative evaluation of pharmacokinetic of CPL-2009-0031 Tablets 140mg of Cadila Pharmaceuticals Ltd.,
India with JANUVIA (Sitagliptin) Tablets 100mg of MSD
Pharmaceuticals Limited, India under fasting and fed condition with a washout period of at least 07 days between each consecutive study periods. |