Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT01677260
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects with absence of significant diseases or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening.
* Age of 18 - 55 years
* Preferably non-smokers or smoke less than 10 cigarettes per day
* Able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study.
* BMI 18 - 25 kg/m2
* Vital signs (after 10 minutes rest) were within the following ranges:
* SBP 100 - 120 mmHg
* DBP 60 - 80 mmHg
* Pulse rate 60 - 90 bpm
Exclusion Criteria:
* Personal/family history of allergy or hypersensitivity or contraindication to metformin hydrochloride or other biguanides and allied drug.
* Pregnant or lactating women and women of childbearing potential without adequate contraception
* Any major illnesses in the past 90 days or clinically significant ongoing chronic medical illnesses
* Clinically significant illness within 4 weeks prior to the administration of study medication
* Presence of any clinically significant abnormal values during screening
* Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV
* Clinically significant haematology abnormalities
* Clinically significant electrocardiogram (ECG) abnormalities
* Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study drug
* History of drug (cocaine, amphetamines, opiates, cannabis) or alcohol abuse within 12 months prior to screening for this study
* Participation in any clinical trial within the past 90 days
* History of any bleeding or coagulative disorders
* History or presence of asthma bronchial or related bronchospastic conditions
* History of seizures, epilepsy or any kind of neurological disorders
* History of difficulty with donating blood or difficulty in vein puncture of left or right arm
* A donation or loss of 500 mL (or more) of blood within 3 months before this study's first dosing day
* Intake of any prescription or non-prescription drugs, food supplements or herbal medicines within 14 days of this study's first dosing day
* Any food allergy, intolerance, restriction or special diet that in the opinion of the Research Physician, could contraindicate the subject's participation in this study
* Any reason in the opinion of the Research Physician, would prevent the subject from participating in the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01677260
Study Brief:
Protocol Section:
NCT01677260