Bioequivalence study on Metformin Hydrochloride 1000 mg tablet with Glucophage 1000 mg tablet (Metformin Hydrochloride 1000 mg) in healthy adult human subjects under fasting conditions
- Registration Number
- CTRI/2022/01/039507
- Lead Sponsor
- ext wave India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 22
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 â?? 30 kg/m2
(both inclusive).
5 Normal haemoglobin between 12.5 to 17.5 grams
per deciliter (g/dL) for men and 12 to 16 g/dL
for female
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 and physical
examination at the time screening as well as
check-in during each study period.
1 Found Positive (+Ve) on Rapid antigen test for
COVID-19 during screening.
2 Haemoglobin level less than 12.5 grams per
deciliter for men and 12 grams per deciliter for
women.
3 Any medical or surgical conditions, which might
significantly interfere with the functioning of
the gastrointestinal tract and bloodâ??forming
organs.
4 History of gastric or duodenal ulcer or GI
bleeding or blood in stools anytime in the past.
5 History of severe infection or major surgery in
the past 6 months.
6 History of Minor surgery or fracture within the
past 3 months
7 Any major illness or hospitalized within 90 days
prior to the first dosing.
8 Any other clinical condition like diarrhea or
vomiting within three days prior to dosing.
9 Subjects who have been on an unusual or
abnormal diet, for whatever reason e.g. because
of fasting due to religious reasons during the
four weeks before screening.
10 Use of any depot injection or an implant of any
drug within three months prior to dosing and
throughout the study periods.
11 History of difficulty in accessibility of veins
in arms.
12 Evidence of an uncooperative attitude.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare rate and extend of orally administered molecule to prove bioequivalence on Metformin Hydrochloride 1000 mg tablet of Next wave with Glucophage 1000 mg tablet (Metformin Hydrochloride 1000 mg) of M/S Merck Serono in healthy adult human subjects under fasting conditions.Timepoint: Day 1 to day 12
- Secondary Outcome Measures
Name Time Method To monitor the safety of the study subjects after administration of Metformin Hydrochloride 1000 mg tablets in healthy adult human subjects under fasting conditionsTimepoint: Day 1 to day 12