CTRI/2025/09/095163 [Registered on: 22/09/2025] Trial Registered Prospectively
Last Modified On:
19/09/2025
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Crossover Trial
Public Title of Study
A study to compare how the body absorbs and processes two brands of Ursodeoxycholic Acid 500 mg tablets in healthy adults under fasting conditions
Scientific Title of Study
An open label, balanced, randomized, truncated, single dose, two treatment, two sequence, two period, crossover, oral bioequivalence study of Ursodeoxycholic Acid Tablet 500 mg by Fourrts (India) Laboratories Pvt. Limited with Ursofalk 500mg tablets (Ursodeoxycholic Acid) of Dr. Falk Pharma GmbH, Germany., in healthy, adult, human subjects under fasting conditions.
Trial Acronym
UDCA-BE500
Secondary IDs if Any
Secondary ID
Identifier
ICBio/027/0425; Ver 00; 20/06/2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Lakshmikar B V
Designation
Principal Investigator
Affiliation
ICBio Clinical Research Private limited
Address
# 2, Survey # 8/1/2 ICBio tower II, Devi Circle, Yelahanka Main Road, Chikkabetahalli, Vidyaranyapura, Bangalore-560097 India
Bangalore KARNATAKA 560097 India
Phone
8069423000
Fax
Email
headcl@icbiocro.com
Details of Contact Person Scientific Query
Name
Dr Lakshmikar B V
Designation
Principal Investigator
Affiliation
ICBio Clinical Research Private limited
Address
# 2, Survey # 8/1/2 ICBio tower II, Devi Circle, Yelahanka Main Road, Chikkabetahalli, Vidyaranyapura, Bangalore-560097 India
Bangalore KARNATAKA 560097 India
Phone
8069423000
Fax
Email
headcl@icbiocro.com
Details of Contact Person Public Query
Name
Dr Lakshmikar B V
Designation
Principal Investigator
Affiliation
ICBio Clinical Research Private limited
Address
# 2, Survey # 8/1/2 ICBio tower II, Devi Circle, Yelahanka Main Road, Chikkabetahalli, Vidyaranyapura, Bangalore-560097 India
Bangalore KARNATAKA 560097 India
Phone
8069423000
Fax
Email
headcl@icbiocro.com
Source of Monetary or Material Support
ICBio Clinical Research Private limited
2, Survey, 8/1/2 ICBio tower II, Devi Circle,
Yelahanka Main Road, Chikkabetahalli, Vidyaranyapura,
Bangalore-560097 India
# 2, Survey # 8/1/2 ICBio tower II, Devi Circle,
Yelahanka Main Road, Chikkabetahalli, Vidyaranyapura,
Bangalore-560097 India Bangalore KARNATAKA
8069423000
headcl@icbiocro.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
ACE Independent Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Fasting
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Reference Product: Ursofalk 500mg tablets (Ursodeoxycholic Acid) of Dr. Falk Pharma GmbH, Germany
After an overnight fast of at least 10.00 hours before scheduled time for dosing, a single dose of the study drug Ursofalk 500mg tablets (Ursodeoxycholic Acid) (Reference Product) will be allocated as per the randomization schedule and administered orally to each subject while in sitting position with approximately 240 ± 5 mL of drinking water in each period at ambient temperature. The subject will be instructed not to chew or crush the Tablet but to swallow it whole
Intervention
Test Product: Ursodeoxycholic Acid Tablet 500 mg by Fourrts (India)
Laboratories Pvt. limited
After an overnight fast of at least 10.00 hours before scheduled time for dosing, a single dose of the study drug Ursodeoxycholic Acid Tablet 500 mg (Test Product) will be allocated as per the randomization schedule and administered orally to each subject while in sitting
position with approximately 240 ± 5 mL of drinking water in each period at ambient temperature. The subject will be instructed not to chew or crush the Tablet but to swallow it
whole
Inclusion Criteria
Age From
18.00 Year(s)
Age To
55.00 Year(s)
Gender
Both
Details
1) Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of the study.
2) Willing to be available for the entire study period and to comply with protocol requirements.
3) Normal, healthy, adult, human subject of 18-55 years (both inclusive) of age.
4) Body mass index in the range of 18.5 – 30.0 kg/m2 (both inclusive).
5) Healthy volunteers who are clinically non-anemic will be included as per the
discretion of PI/CI/Physician.
6) Normal health status as determined by baseline medical and medication
history, at the time of screening and vital signs (blood pressure, pulse rate,
respiratory rate and axillary temperature) measurements at the time screening
as well as check-in during check-out of each study period.
7) With normal or clinically non-significant laboratory values as determined by
hematological, biochemistry tests and urine analysis.
8) With a normal or clinically non-significant 12-lead ECG.
9) With a negative test for Human Immunodeficiency Virus (HIV) type I/II
antibodies or Hepatitis B surface antigen (HBsAg) or Hepatitis C virus
antibodies.
10) Non-smokers and willing to abstain from smoking or chewing any tobacco
containing product at least 72.00 hours prior to dosing if have history of
smoking habit and throughout the sampling points.
11) Male volunteer willing to use appropriate contraceptive measures to ensure
that his female partner will not get pregnant for at least 15 days before 1st
dosing till 15 days post last-dose/ entire study period.
12) In case of female subjects:
13) Negative urine pregnancy test during screening and negative serum beta -hCG test at check-in of each study period.
14) Female subjects with childbearing potential or those within their first two
years of onset of menopausal syndrome must either abstain from sexual
intercourse or using acceptable methods of birth control for at least 15
days before 1st dosing till 15 days post last-dose/ entire study period
[Acceptable birth control methods include barrier methods such as
diaphragm/condom with or without spermicide or who are surgically
sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)
has been performed].
15) Able to read and understand the Informed Consent Document as a whole and
communicate effectively if required
ExclusionCriteria
Details
1) Incapable of understanding the informed consent information.
2) History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
3) History or presence of severe renal dysfunction, including those receiving dialysis and hepatic dysfunction.
4) History or presence of active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities
5) History or presence of pre-existing gallbladder disease.
6) History or presence of mortality and coronary heart disease morbidity
7) Use of antihypertensive drugs and pressor Agents (e.g. dopamine,
dobutamine), use of CYP2D6 (e.g., paroxetine, fluoxetine, and quinidine), use of monoamine oxidase Inhibitors in the previous 30 days before first drug administration and till the completion of the study.
8) History or presence of asthma, urticaria or other allergic reactions.
9) History or presence of gastric and/or duodenal ulceration.
10) History or presence of thyroid disease, adrenal dysfunction, organic
intracranial lesion.
11) History or presence of cancer.
12) Difficulty with donating blood.
13) Difficulty in swallowing solids like tablets.
14) Use of any prescribed medication (including herbal medicines, vitamin supplements, Bile Acid Sequestering Agents and Aluminium based Antacids) during the two weeks before the start of the study or vitamins, herbal products and OTC medicinal products during two weeks prior to study initiation.
15) Subject chewed tobacco / consumed pan or pan masala, gutkha, masala
(containing beetle nut and tobacco), xanthine-containing foods or beverages (coffee, tea, chocolate, and caffeine-containing sodas, colas, etc) for 48.00 hours prior to initiation of the study till the end of the study.
16) Subjects consumed grapefruit juice and poppy containing foods for 72.00 hours prior to initiation of the study till the end of the study.
17) Subjects consumed alcohol or alcoholic products for at-least 24.00 hrs prior to check-in in each study period and throughout sampling time points
18) Major illness during the 180 days before screening.
19) Participation in a drug research study within 90 days of screening.
20) Donation of blood within 90 days of screening.
21) Positive screening test result for any one or more of the following: HIV, Hepatitis B, Hepatitis C and VDRL.
22) Positive result for urinary screen test for drugs of abuse (amphetamines, morphine, benzodiazepines, marijuana, cocaine and barbiturate).
23) Subjects with positive test results for urine pregnancy test for female subjects.
24) History or presence of easy bruising or bleeding.
25) Abnormal diet patterns (for any reason) during the four weeks preceding the study, including fasting, high protein, low sodium diets etc.
26) Use of any hormone replacement therapy within 3 months prior to the first dose of study medication.
27) A depot injection or implant of any drug within 3 months prior to the first dose of study medication.
28) Pregnant woman and nursing mothers.
29) History of allergy or hypersensitivity intolerance to Ursodeoxycholic acid or its formulation excipients which, in the opinion of the clinical investigator, would compromise the safety of the subject or the study.
30) History of difficulty in accessibility of veins in arms.
31) Evidence of an uncooperative attitude.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pharmacy-controlled Randomization
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To compare the rate and extent of absorption of Ursodeoxycholic Acid Tablet
500 mg by Fourrts (India) Laboratories Pvt. Limited with Ursofalk 500mg tablets
(Ursodeoxycholic Acid) of Dr. Falk Pharma GmbH, Germany., in healthy, adult,
human subjects under fasting conditions
The venous blood samples will be withdrawn at pre-dose (-24.00, -18.00, -12.00, -6.00 and 0.00 hours) and at 0.12, 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 12.00, 24.00, 48.00 and 72.00 hours post dose following drug administration in each period.
Secondary Outcome
Outcome
TimePoints
To monitor the safety and tolerability of the study subjects after administration
of Ursodeoxycholic Acid Tablet 500 mg in healthy, adult, human subjects, under
fasting conditions.
Vital signs (blood pressure, pulse rate, respiratory rate and
axillary/body temperature) measurement station
Before check-in (-36.00) and at Pre-dose [-24.00, -18.00,
-12.00 [within ± 01 hour of scheduled time of recording] and
0.00 (within 2.00 hr before dosing)], at 3.00, 7.00, and 11.00
hours after dosing [within ± 60 minutes of scheduled time of
recording], at the time of checkout in each period and at each ambulatory visits in each period.
The well-being of subjects will be ascertained at each vital sign measurement.
Target Sample Size
Total Sample Size="12" Sample Size from India="12" 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)
12/11/2025
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="8"
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
Descriptive statistics of primary and secondary pharmacokinetic parameters will be computed and reported for Baseline corrected and uncorrected Unconjugated ursodiol and total (conjugated and unconjugated) ursodiol in plasma. ANOVA, 90% confidence interval using schuirmann’s two one-sided tests for bioequivalence, power and ratio analysis, for ln-transformed pharmacokinetic parameters Cmax and AUC0-72 will be computed and reported for Baseline corrected and uncorrected Unconjugated ursodiol and total (conjugated and unconjugated) ursodiol.
BE Criteria: Based on the statistical results of 90% confidence interval for the ratio of the geometric least squares means for lntransformed pharmacokinetic parameters Cmax and AUC0-72 for Baseline corrected and uncorrected Unconjugated ursodiol and total (conjugated and unconjugated) ursodiol, conclusion will be drawn for Test Product-T vs. Reference Product-R. Bioequivalence of the test product with that of the reference product will be concluded if 90% confidence interval falls within the acceptance range of 80.00-125.00% for lntransformed pharmacokinetic parameters Cmax and AUC0-72 for Baseline corrected Unconjugated ursodiol and total (conjugated and unconjugated) ursodiol. Note: Baseline Correction Method The mean of the pre-dose Unconjugated ursodiol and total (conjugated and unconjugated) ursodiol levels should be used for the baseline adjustment of the post-dose levels. Baseline concentrations should be determined for each dosing period, and baseline corrections should be period specific. If a negative plasma concentration value results after baseline correction, this should be set to 0 prior to calculating the baseline-corrected AUC. The Unconjugated ursodiol and total (conjugated and unconjugated) ursodiol pharmacokinetic parameters should be determined based on both baselinecorrected and baseline un-corrected plasma concentration data