HealthyNCT00780013
Bioequivalence Study of Metformin Hydrochloride Liquid 500mg/ 5 mL Under Fed Conditions
A study testing metformin hydrochloride liquid 500 mg per 5 mL in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in Canada.
Trial summary
The objective of this study was to compare the single-dose oral bioavailability of metformin hydrochloride (HCI) liquid 500 mg/5 mL of Ranbaxy with GlucophageA® 1000 mg tablets of Bristol-Myers, USA following administration of a 1000 mg dose in healthy, adult, male and female volunteers under fed conditions 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 hydrochloride liquid 500 mg per 5 mL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- May 2002to Jun 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.
- Weigh at least 60 kg for males and 52 kg for females and be within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1953).
- Have voluntarily given written informed consent to participate in this study.
- Be medically healthy with clinically normal laboratory profiles as determined by medical history, physical examination and laboratory tests performed within 28 days prior to the commencement of the study.
- Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to the study and throughout the study or be using one of the following acceptable birth control methods:
- Surgically sterile (tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum. Proof is required for the hysterectomy and oophorectomy;
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- IUD in place for at least 3 months
- Barrier methods with spermicide (condom, diaphragm) for at least 14 days prior to the start of the study and throughout the study
- Surgical sterilization of the partner (vasectomy for 6 months minimum)
- Hormonal contraceptives for at least 3 months prior to the start of the study. Other birth control methods may be deemed acceptable. Post-menopausal women with amenorrhea for at least 2 years will be eligible.All female subjects will be asked to confirm compliance with an approved and effective method of birth control and to sign a declaration form to this effect.
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
- History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, endrocrine, immunologic, dermatologic, neurological or haematological
- 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 from 1 hour before dosing and up to 6 hour following drug administration in each study period.
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- Subjects who have had problems with drug or alcohol abuse within the past year or will have difficulty in abstaining for the duration of each study period.
- Participation in any clinical trial within 28 days of study start
- Subjects who have been on an abnormal diet (for whatever reason) during the 28 days preceding the first dosing.
- Females who are pregnant or lactating.
- Subjects without adequate venous access in their left or right arm to allow collection of 38 blood samples via venipuncture in the 2 periods.
- Subjects who, through completion of the study, would have donated in excess of:
- 500 mL of blood in 14 days 500 - 750 mL of blood in 14 days (unless approved by the Principal Investigator) 1000 mL of blood in 90 days 1250 mL of blood in 120 days 1500 mL of blood in 180 days 2000 mL of blood in 270 days 2500 mL of blood in 1 year 13) Presence of values that are significantly different from normal reference ranges, as judged by the physician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Crossover Bioavailability Study on Metformin Formulations Comparing Metformin Hydrochloride Liquid 500 mg/5mL of Ranbaxy Laboratories With GlucophageA® 1000 mg Tablets of Bristol-Myers Squibb in Healthy, Adult, Male and Female Volunteers Under Fed Conditions, Following a 1000 mg Dose
The objective of this study was to compare the single-dose oral bioavailability of metformin hydrochloride (HCI) liquid 500 mg/5 mL of Ranbaxy with GlucophageA® 1000 mg tablets of Bristol-Myers, USA following administration of a 1000 mg dose in healthy, adult, male and female volunteers under fed conditions
Read the detailed description
This was an open-label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose crossover bioavailability study performed on 36 healthy adult male and female non-smoking or light smoking volunteers and 2 alternates. A total of 36 subjects completed the clinical phase of the study. In each period, subjects were housed from the evening before dosing until after the 24-hour blood draw. Single oral 1000 mg doses were separated by a washout period of 7 days Of the 36 healthy adult non-smoking or light-smoking (10 cigarettes/day) volunteers and 2 alternates (19 males, 19 non-pregnant females) enrolled in the study, two did not complete the clinical phase of the study. Subject No. 11 was withdrawn from the study by the on-duty Physician after a positive pregnancy test prior to dosing in Period 2 and Subject No. 20 was withdrawn from the study by the Clinical Study Manager after she failed to complete her breakfast prior to dosing in Period 2. Thus a total of 36 subjects completed the clinical phase of the study
- Conditions
- Healthy
- Being tested
- metformin hydrochloride liquid 500 mg per 5 mL
- Keywords
- Bioequivalence metformin hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metformin hydrochloride liquid 500 mg per 5 mLDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | metformin hydrochloride (HCI) liquid 500 mg/5 mL of Ranbaxy Receives: Drug: metformin hydrochloride liquid 500 mg per 5 mL |
| 2 | Active comparator | Glucophage® 1000 mg tablets Receives: Drug: metformin hydrochloride liquid 500 mg per 5 mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startMay 2002
- Primary completionMay 2002
- Study completionJun 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ranbaxy Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00780013
- Sponsor's protocol ID
- 05/METFO-500/01
- Status last verified
- Oct 2008
- First submitted
- 22 Oct 2008
- Last updated
- 24 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crossover Bioavailability Study on Metformin Formulations Comparing Metformin Hydrochloride Liquid 500 mg/5mL of Ranbaxy Laboratories With GlucophageA® 1000 mg Tablets of Bristol-Myers Squibb in Healthy, Adult, Male and Female Volunteers Under Fed Conditions, Following a 1000 mg Dose
- ClinicalTrials.gov ID
- NCT00780013
- Acronym / sponsor ID
- 05/METFO-500/01
- Conditions
- Healthy
- Keywords
- Bioequivalence metformin hydrochloride
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ranbaxy Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- May 2002
- Primary completion
- May 2002 (actual)
- Study completion
- Jun 2002 (actual)
- First posted
- 24 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.
The objective of this study was to compare the single-dose oral bioavailability of metformin hydrochloride (HCI) liquid 500 mg/5 mL of Ranbaxy with GlucophageA® 1000 mg tablets of Bristol-Myers, USA following administration of a 1000 mg dose in healthy, adult, male and female volunteers under fed conditions
Detailed description
This was an open-label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose crossover bioavailability study performed on 36 healthy adult male and female non-smoking or light smoking volunteers and 2 alternates. A total of 36 subjects completed the clinical phase of the study. In each period, subjects were housed from the evening before dosing until after the 24-hour blood draw. Single oral 1000 mg doses were separated by a washout period of 7 days Of the 36 healthy adult non-smoking or light-smoking (10 cigarettes/day) volunteers and 2 alternates (19 males, 19 non-pregnant females) enrolled in the study, two did not complete the clinical phase of the study. Subject No. 11 was withdrawn from the study by the on-duty Physician after a positive pregnancy test prior to dosing in Period 2 and Subject No. 20 was withdrawn from the study by the Clinical Study Manager after she failed to complete her breakfast prior to dosing in Period 2. Thus a total of 36 subjects completed the clinical phase of the study
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: metformin hydrochloride liquid 500 mg per 5 mLmetformin hydrochloride (HCI) liquid 500 mg/5 mL of Ranbaxy |
| 2 | Active comparator | Drug: metformin hydrochloride liquid 500 mg per 5 mLGlucophage® 1000 mg tablets |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Be in the age range of 18-45 years.
- Weigh at least 60 kg for males and 52 kg for females and be within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1953).
- Have voluntarily given written informed consent to participate in this study.
- Be medically healthy with clinically normal laboratory profiles as determined by medical history, physical examination and laboratory tests performed within 28 days prior to the commencement of the study.
- Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to the study and throughout the study or be using one of the following acceptable birth control methods:
Key exclusion criteria (13 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
- History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, endrocrine, immunologic, dermatologic, neurological or haematological
- disease, diabetes or glaucoma.
- History of any psychiatric illness which may impair the ability to provide written informed consent.
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 hydrochloride liquid 500 mg per 5 mL | Drug | 1, 2 |
Primary outcome
Bioequivalence
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 24 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing metformin hydrochloride liquid 500 mg per 5 mL in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in Canada.
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 10 inclusion and 13 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 24 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Bioequivalence. 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 24 Oct 2008.