HealthyPhase 1NCT01133496
Bioequivalence Study of Alendronate Sodium Tablets 70 mg of Dr. Reddy's Under Fasting Conditions
A Phase 1 study testing Alendronate Sodium Tablets, 70 mg in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in India.
Trial summary
The purpose of this study is to determine the bioequivalence of Alendronate Sodium 70 mg of Dr. Reddy's and Fosamax Tablets 70 mg of Merck \& Co. 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?
- Alendronate Sodium Tablets, 70 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2006to Apr 2007
- Phase
- Phase 1
- 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
- Healthy human subjects aged between 18 and 45 years (including both).
- Subjects with a BMI between 18.5 - 24.9 Kg/m2 but weight not less than 45 Kgs.
- Female subjects who are postmenopausal or surgically sterile.
- Female subjects of child bearing potential 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.
- Subjects with normal health as determined by personal medical history, clinical examination, and laboratory examinations and serology tests.
- Subjects having normal 12-lead electrocardiogram (ECG).
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- Subjects having normal chest X-Ray (P/A view).
- Subjects able to communicate effectively.
- Subjects willing to given written informed consent and adhere to all the requirements of this protocol.
Who cannot join
- Subjects having contraindications or hypersensitivity to Alendronate sodium or related drugs.
- History or presence of any medical condition or disease according the opinion of the physician.
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- History or presence of significant alcoholism or drug abuse in the past one year.
- History or presence of significant smoking (more than 10 cigarettes or beedi's/day or consumption of tobacco products).
- Difficulty with donating blood.
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- Difficulty in swallowing solids like tablets or capsules.
- Systolic blood pressure less than 90 mm Hg or more than 140 mm Hg.
- Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
- Pulse rate less than 50/minute or more than 100/minute.
- Use of any prescribed medication during last two weeks or OTC medical products during the last one week preceding the first dosing.
- Major illness during 3 months before screening.
- Participation in a drug research study within past 3 months.
- Donation of blood in the past 3 months before screening.
- Female volunteers demonstrating a positive pregnancy screen.
- Female volunteers who are currently breast-feeding.
- Female volunteers with child bearing potential using prohibited contraceptive method (Oral, Injectable or Implantable hormonal agents).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label, Balanced, Randomized, Two-way, Single-dose, Crossover Bioequivalence Study of Alendronate Sodium 70 mg Tablets of Dr Reddy's, India and Fosamax® Tablets of Merck & Co., Inc., USA, in Healthy Subjects Under Fasting Conditions
The purpose of this study is to determine the bioequivalence of Alendronate Sodium 70 mg of Dr. Reddy's and Fosamax Tablets 70 mg of Merck \& Co.
Read the detailed description
Open label, balanced, randomized, two-treatment, two-sequence, two-period, single-dose, crossover oral bioequivalence study of Alendronate sodium 70 mg tablets of Dr Reddy's Laboratories Limited, India and Fosamax® tablets of Merck \& Co., Inc., USA, in healthy, adult, human subjects under fasting conditions.
- Conditions
- Healthy
- Being tested
- Alendronate Sodium Tablets, 70 mg
- Keywords
- Bioequivalence, Alendronate Sodium, crossover
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alendronate Sodium Tablets, 70 mgDrug
Also called Fosamax Tablets 70 mg
Alendronate Sodium Tablets, 70 mg of Dr. Reddy's Laboratories Limited.
| Study group | Role | What they receive |
|---|---|---|
| Alendronate Sodium | Experimental | Alendronate Sodium Tablets, 70 mg of Dr. Reddy's Receives: Drug: Alendronate Sodium Tablets, 70 mg |
| Fosamax | Active comparator | Fosamax Tablets 70 mg of Merck \& Company. Inc., USA. Receives: Drug: Alendronate Sodium Tablets, 70 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence based on Cmax and AUC parameters
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startDec 2006
- Primary completionDec 2006
- Study completionApr 2007
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dr. Naba Kr Talukdar, MD, Principal investigator, GVK Biosciences Pvt. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133496
- Sponsor's protocol ID
- 095-06
- Status last verified
- Jun 2010
- First submitted
- 27 May 2010
- Last updated
- 14 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Balanced, Randomized, Two-way, Single-dose, Crossover Bioequivalence Study of Alendronate Sodium 70 mg Tablets of Dr Reddy's, India and Fosamax® Tablets of Merck & Co., Inc., USA, in Healthy Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT01133496
- Acronym / sponsor ID
- 095-06
- Conditions
- Healthy
- Keywords
- Bioequivalence, Alendronate Sodium, crossover
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 28 May 2010 (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 purpose of this study is to determine the bioequivalence of Alendronate Sodium 70 mg of Dr. Reddy's and Fosamax Tablets 70 mg of Merck \& Co.
Detailed description
Open label, balanced, randomized, two-treatment, two-sequence, two-period, single-dose, crossover oral bioequivalence study of Alendronate sodium 70 mg tablets of Dr Reddy's Laboratories Limited, India and Fosamax® tablets of Merck \& Co., Inc., USA, in healthy, adult, human subjects under fasting conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alendronate Sodium | Experimental | Drug: Alendronate Sodium Tablets, 70 mgAlendronate Sodium Tablets, 70 mg of Dr. Reddy's |
| Fosamax | Active comparator | Drug: Alendronate Sodium Tablets, 70 mgFosamax Tablets 70 mg of Merck \& Company. Inc., USA. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy human subjects aged between 18 and 45 years (including both).
- Subjects with a BMI between 18.5 - 24.9 Kg/m2 but weight not less than 45 Kgs.
- Female subjects who are postmenopausal or surgically sterile.
- Female subjects of child bearing potential 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.
- Subjects with normal health as determined by personal medical history, clinical examination, and laboratory examinations and serology tests.
Key exclusion criteria (17 listed)
- Subjects having contraindications or hypersensitivity to Alendronate sodium or related drugs.
- History or presence of any medical condition or disease according the opinion of the physician.
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- History or presence of significant alcoholism or drug abuse in the past one year.
- History or presence of significant smoking (more than 10 cigarettes or beedi's/day or consumption of tobacco products).
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 |
|---|---|---|
| Alendronate Sodium Tablets, 70 mgAlso: Fosamax Tablets 70 mgAlendronate Sodium Tablets, 70 mg of Dr. Reddy's Laboratories Limited. | Drug | Alendronate Sodium, Fosamax |
Primary outcome
Bioequivalence based on Cmax and AUC parameters
Time frame: 5 months
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 14 Jun 2010.
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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.
Dr. Naba Kr Talukdar, MD principal investigator
GVK Biosciences Pvt. Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alendronate Sodium Tablets, 70 mg in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in India.
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 9 inclusion and 17 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 14 Jun 2010. 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 India. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 based on Cmax and AUC parameters (time frame: 5 months). 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 14 Jun 2010.