HealthyNCT00778349
A Comparitive Bioavailability Study of Metformin Hydrochloride Liquid 500mg/ 5 mL Under Fasting Conditions and After Low and High Fat Meal
A study testing Metformin solution 100 mg/mL in people with Healthy, run by Ranbaxy Laboratories Limited.
Trial summary
To assess the food effect on pharmacokinetic profile of metformin liquid 100 mg/mL of Ranbaxy Laboratories in healthy, adult, human subjecis following a dose administration of 10 mL (1000 mg) under fasting conditions, after a Iow fat meal and after a high fat meal Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Metformin solution 100 mg/mL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Apr 2002to Jul 2002
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be in the age range of 18.45 years.
- Be neither overweight nor underweight for his/her height as per the Life Insurance Corporation of India height/weight chart for non-medical cases.
- Have voluntarily given written informed consent to participate in this study.
- Be of normal health as determined by medical history and physical
- Examination of the subjects performed .within 28 days prior to the commencement of the study.
- If female and:
- Of childbearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence; or~ Is postmenopausal for at least 1 year; or Is surgically sterile bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
Who cannot join
- History of allergy to metformin and other related antidiabetic biguanide preparations.
- Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
- Presence of disease markers of HIV 1 and 2, Hepatitis B and C viruses and syphilis infection.
- Female volunteers demonstrating a positive pregnancy screen.
- Female volunteers who are currently breastfeeding.
- Presence of values' which are clinically significantly different from normal reference ranges for hemoglobin, total white blood cells count, differential WBC count and platelet count
Show all 14Show fewer
- Positive for urinary screen testing of drugs of abuse (opiates and cannabinoids
- Presence of values which are significantly different from normal.reference ranges (as defined in Appendix 5) for se- rum creatinine, blood urea nitrogen serum aspartate aminotransferase (AST), serum alanine aminotranferase (ALT), serum alkaline phosphatase, serum billrubin, plasma glucose and serum cholesterol
- Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (>4/HPF), epithelial cells (>4/HPF), glucose, (positive) and protein (positive).
- History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or hematological disease, diabetes or glaucoma.
- History of any psychiatric illness. which may impair the ability to provide written informed consent.
- Regular smokers who smoke more than 10 cigarettes daily or have difficulty abstaining from smoking for the duration of each study period.
- History of drug dependence or excessive alcohol intake on a habitual basis of more than 2 units of alcoholic beverages per day (1 'unit equivalent to half pint of beer or 1 glass of wine or 1 measure of spirit) or have difficulty in abstaining for the duration of each study period.
- Use of any enzyme modifying drugs within 30 days prior to Day I of this study
About this study
Official title: A Randomized, Three-Treatment, Three-Period, Six-Sequence, Single-Dose, Crossover Pharmacokinetic Study on Metformin Hydrochloride Solution 100 mg/mL of Ranbaxy Laboratories Comparing the Pharmacokinetic Profile of Metformin Under Fasting Condition, After a Low Fat Meal and After a High Fat Meal in Healthy, Adult, Human Male Subjects.
To assess the food effect on pharmacokinetic profile of metformin liquid 100 mg/mL of Ranbaxy Laboratories in healthy, adult, human subjecis following a dose administration of 10 mL (1000 mg) under fasting conditions, after a Iow fat meal and after a high fat meal
Read the detailed description
This study was an open label, randomized, three-treatment, three-period, six-sequence, single-dose, crossover pharmacokinetic study planned on 36 healthy, adult, human subjects under fasting conditions. However 34 subjects were enrolled and 33 subjects completed all the periods of the study. All periods were separated by a washout of seven days As per protocol (Appendix 1), enough healthy, adult, human subjects were to be enrolled in the study to allow the dosing of 36 subjects in the first period. 34 subjects were enrolled and 33 subjects completed all the periods of study
- Conditions
- Healthy
- Being tested
- Metformin solution 100 mg/mL
- Keywords
- Bioavailability Metformin solution 100 mg/mL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin solution 100 mg/mLDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Metformin solution 100 mg/mL under fasting condition Receives: Drug: Metformin solution 100 mg/mL |
| 2 | Experimental | Metformin solution 100 mg/mL, after low fat meal Receives: Drug: Metformin solution 100 mg/mL |
| 3 | Experimental | Metformin solution 100 mg/mL, after high fat meal Receives: Drug: Metformin solution 100 mg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2008 (estimated)
- Study startApr 2002
- Primary completionMay 2002
- Study completionJul 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ranbaxy Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00778349
- Sponsor's protocol ID
- 04/METFO-500/02
- Status last verified
- Oct 2008
- First submitted
- 22 Oct 2008
- Last updated
- 23 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Three-Treatment, Three-Period, Six-Sequence, Single-Dose, Crossover Pharmacokinetic Study on Metformin Hydrochloride Solution 100 mg/mL of Ranbaxy Laboratories Comparing the Pharmacokinetic Profile of Metformin Under Fasting Condition, After a Low Fat Meal and After a High Fat Meal in Healthy, Adult, Human Male Subjects.
- ClinicalTrials.gov ID
- NCT00778349
- Acronym / sponsor ID
- 04/METFO-500/02
- Conditions
- Healthy
- Keywords
- Bioavailability Metformin solution 100 mg/mL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Ranbaxy Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Apr 2002
- Primary completion
- May 2002 (actual)
- Study completion
- Jul 2002 (actual)
- First posted
- 23 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the food effect on pharmacokinetic profile of metformin liquid 100 mg/mL of Ranbaxy Laboratories in healthy, adult, human subjecis following a dose administration of 10 mL (1000 mg) under fasting conditions, after a Iow fat meal and after a high fat meal
Detailed description
This study was an open label, randomized, three-treatment, three-period, six-sequence, single-dose, crossover pharmacokinetic study planned on 36 healthy, adult, human subjects under fasting conditions. However 34 subjects were enrolled and 33 subjects completed all the periods of the study. All periods were separated by a washout of seven days As per protocol (Appendix 1), enough healthy, adult, human subjects were to be enrolled in the study to allow the dosing of 36 subjects in the first period. 34 subjects were enrolled and 33 subjects completed all the periods of study
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Metformin solution 100 mg/mLMetformin solution 100 mg/mL under fasting condition |
| 2 | Experimental | Drug: Metformin solution 100 mg/mLMetformin solution 100 mg/mL, after low fat meal |
| 3 | Experimental | Drug: Metformin solution 100 mg/mLMetformin solution 100 mg/mL, after high fat meal |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Be in the age range of 18.45 years.
- Be neither overweight nor underweight for his/her height as per the Life Insurance Corporation of India height/weight chart for non-medical cases.
- Have voluntarily given written informed consent to participate in this study.
- Be of normal health as determined by medical history and physical
- Examination of the subjects performed .within 28 days prior to the commencement of the study.
Key exclusion criteria (14 listed)
- History of allergy to metformin and other related antidiabetic biguanide preparations.
- Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
- Presence of disease markers of HIV 1 and 2, Hepatitis B and C viruses and syphilis infection.
- Female volunteers demonstrating a positive pregnancy screen.
- Female volunteers who are currently breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin solution 100 mg/mL | Drug | 1, 2, 3 |
Primary outcome
Bioavailability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2008.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin solution 100 mg/mL in people with Healthy, run by Ranbaxy Laboratories Limited.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioavailability. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2008; AzTrials last refreshed its copy on 6 Nov 2026.