| CTRI Number |
CTRI/2022/09/046057 [Registered on: 30/09/2022] Trial Registered Prospectively |
| Last Modified On: |
29/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
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Type of Study
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| Study Design |
Randomized, Crossover Trial |
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Public Title of Study
|
Bioequivalence study of Dydrogesterone against Duphaston |
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Scientific Title of Study
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An Open-Label, Randomized, Single Oral Dose, Two-Period, Cross-Over Trial to Assess the Bioequivalence of Dydrogesterone 10mg tablets (Test Drug) of Medethix Inc. in Comparison with Tab. Duphaston (Dydrogesterone) 10mg tablets (Reference Drug) of Abbott Labs. in Healthy Female
Subjects Under Fasting Conditions.
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| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BESRS/2203 ver 1.0 dated 01 Feb 2022 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nitin Kulkarni |
| Designation |
Principal Investigator |
| Affiliation |
CliNovi Research Pvt Ltd |
| Address |
MITHRAN MALL MUMBAI BANGALORE HIGHWAY
TATHAWADE Pune
Pune
MAHARASHTRA
411033
India |
| Phone |
9742797117 |
| Fax |
|
| Email |
info@samahitha.com |
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Details of Contact Person
Scientific Query
|
| Name |
Sri Vatsa G S |
| Designation |
Managing Director |
| Affiliation |
Samahitha Research Solutions |
| Address |
Second floor No.1204 ASHVA
26th Main Jayanagar 9th Block Bangalore
Bangalore
KARNATAKA
560069
India |
| Phone |
06364147979 |
| Fax |
|
| Email |
sri@samahitha.com |
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Details of Contact Person
Public Query
|
| Name |
Disha Shetty |
| Designation |
Project Manager |
| Affiliation |
Samahitha Research Solutions |
| Address |
Second floor No.1204 ASHVA
26th Main Jayanagar 9th Block Bangalore
Bangalore
KARNATAKA
560069
India |
| Phone |
06364147979 |
| Fax |
|
| Email |
disha@samahitha.com |
|
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Source of Monetary or Material Support
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Primary Sponsor
|
| Name |
Medethix Inc |
| Address |
6F RFM Corporate Center, Pioneer St.,
Mandaluyong City, Philippines 1550
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| Type of Sponsor |
Pharmaceutical industry-Global |
|
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nithin Kulkarni |
Clinovi Research Pvt Ltd |
Mithran Mall Mumbai Bangalore Highway Thathawade Pune
Pune
MAHARASHTRA |
8884709444
info@samahitha.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Skinovate Independent Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Healthy Human Volunteers |
Not Applicable |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Duphaston |
Single dose of Duphaston 10mg Tablet aids in infertility by preparing the womb lining for pregnancy |
| Intervention |
Dydrogesterone |
Dydrogesterone is an orally active progestogen which acts directly on the uterus, producing a complete secretory endometrium in an estrogen-primed uterus
Single dose of 10mg would be administered. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1) Volunteers with age of 18 to 45 years old, both inclusive.
2) Non-pregnant, non-lactating female.
a. Female of childbearing potential must have a negative serum beta human chorionic gonadotropin pregnancy test performed within 28 days prior to first dosing day & prior to check-in of each period. They must be using an acceptable form of contraception.
b. For female of childbearing potential, acceptable forms of contraception include any one of the following:
• Non hormonal intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study
Barrier methods containing or used in conjunction with a spermicidal agent
Surgical sterilization
Practicing sexual abstinence throughout the course of the study.
Female will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
Postmenopausal with spontaneous amenorrhea for at least one year, or
Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
Total hysterectomy and an absence of bleeding for at least 3 months.
18.5 to 30.0 weight in kg /m2, both inclusive
Able to communicate effectively with study personnel.
Able to give written informed consent to participate in the study.
All volunteers must be judged by the principal or sub-investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 days of the first dose of study medication which will include:
A physical examination with no clinically significant finding.
Results within normal limits or clinically non-significant for the following tests: Hematology, Blood Chemistry, Urinalysis, Immunological Tests, Serum (β-HCG) Pregnancy Test (for female of child bearing potential)
• Additional tests and/or examinations may be performed, if necessary, based on Principal Investigator discretion. |
|
| ExclusionCriteria |
| Details |
1) History of allergic responses to Dydrogesterone or other related drugs, or any of its formulation ingredients.
2) Known or suspected progestogen dependant neoplasms
3) Volunteer with undiagnosed irregular vaginal bleeding.
4) Volunteer with hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
5) Have significant diseases or clinically significant abnormal findings during screening
6) Any disease or condition like diabetes, psychosis, adrenal insufficiency, thyrotoxicosis, seizures or others which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, endocrine or any other body system.
7) Use of any hormone replacement therapy within 3 months prior to the first dose of study medication.
8) Use of enzyme-modifying drugs within 30 days prior to the first dose of study medication.
9) Use of estrogens 30 days prior to the first dose of study medication and throughout the study.
10) History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
11) Smokers who smoke 10 or more cigarettes per day or 20 or more biddies per day or those who cannot refrain from smoking during the study period.
12) History of difficulty with donating blood or difficulty in accessibility of veins.
13) A positive hepatitis screen (includes subtypes B and C).
14) A positive test result for HV antibody and/ or syphilis (RPR/VDRL).
15) Volunteers who have received a known investigational drug within ten elimination half-life of the administered drug prior to the first dose of study medication or have donated blood or loss of blood 50 mL to 100 mL within 30 days or 101 mL to 200 mL within 60 days or >200 mL within 90 days (excluding volume drawn at screening for this study) prior to first dose of study medication, whichever is greater.
16) History of difficulty in swallowing or of any gastrointestinal disease which could affect drug absorption.
17) Intolerance to venipuncture.
18) Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Sub-Investigator, could contraindicate the volunteer participation in this study.
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| Bioavailability of the test product Dydrogesterone 10 mg is compared against the innovator Duphaston 10mg. |
17 days |
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Secondary Outcome
|
| Outcome |
TimePoints |
| AUC, Cmax and Tmax |
Between Day 1 and Day 17 across 2 periods |
|
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Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
Final Enrollment numbers achieved (Total)= "28"
Final Enrollment numbers achieved (India)="28" |
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Phase of Trial
|
N/A |
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Date of First Enrollment (India)
|
03/10/2022 |
| Date of Study Completion (India) |
25/10/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
|
None yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
Modification(s)
|
Objectives: - To compare and evaluate the oral bioavailability of Dydrogesterone 10mg tablets (Test Drug) Of Medethix Inc. In Comparison with Duphaston (Dydrogesterone) 10mg tablets (Reference Drug) Of Abbott Labs. in Healthy Female Subjects Under Fasting Conditions in healthy, adult, human subjects under fasting conditions.
- To monitor the safety of the subjects
Study Design:
- An open label, randomized, two-period, two-treatment, two-sequence, crossover, balanced, single dose oral bioequivalence study.
Study Duration: - Considering the 7 days washout period, expected study duration of clinical part is 17 days from the day of check-in of first period.
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