HealthyNCT00776646
Bioequivalence Study of Hydrochlorothiazide 50mg Tablets Under Fasting Conditions
A study testing hydrochlorothiazide 50 mg tablet in people with Healthy, run by Ranbaxy Laboratories Limited.
Trial summary
To compare the single-dose oral bioavailability of hydrochlorothiazide 50 mg tablet of Ohm Laboratories (A subsidiary of Ranbaxy pharmaceuticals USA) with hydrochlorothiazide 50 mg tablet of IVAX Pharmaceuticals, USA in healthy, adult, human, male subjects under fasting condition Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- hydrochlorothiazide 50 mg tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- May 2006to Aug 2006
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-45 years.
- Were neither overweight nor underweight for his height as per the Life Insurance Corporation of India height/weight chart for non-medical cases.
- Had voluntarily given written informed consent to participate in this study.
- Were of normal health as determined by medical history and physical examination of the subjects performed within 21 days prior to the commencement of the study.
Who cannot join
- - Had history of allergy or hypersensitivity to hydrochlorothiazide or any other sulphonamide derived drugs.
- Had history of diarrhoea, vomiting or headache within past two weeks
- Had history of hypotension (systolic BP<100 mmHg)
- Had history of allergy or bronchial asthma
- Had history of muscle cramps or muscle weakness
- Had history of any anaphylactic reactions, necrotizing angiitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, photosensitivity, fever, urticaria, rash, purpura, Systemic Lupus Erythematoses(SLE)
Show all 27Show fewer
- Had history of aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia
- Had history of anuria or history/evidence of any renal disorder including renal failure, renal dysfunction, interstitial nephritis.
- Had history of erythema multiforme including Stevens- Johnson syndrome or exfoliative dermatitis including toxic epidermal necrolysis
- Had history of pancreatitis
- Had history/evidence of jaundice or any hepatic or gall bladder disease
- Had history of hyperglycemia, glycosuria, hyperuricemia or gout.
- The subject had a history/evidence of any electrolyte imbalance, serum sodium < 135 mEq/L, serum potassium < 3.5 mEq/ L.
- Had any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
- Had presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.
- Had presence of values, which are significantly different from normal, reference and/or judged clinically significant for haemoglobin, total white blood cells count, differential WBC count or platelet count.
- Had positive for urinary screen testing of drugs of abuse (opiates or cannabinoids)
- Had presence of values, which are significantly different from normal, reference ranges and/or judged clinically significant for serum creatinine, blood urea nitrogen, serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase, serum bilirubin, plasma glucose or serum cholesterol.
- Had clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (>4/HPF), epithelial cells (>4/HPF), glucose (positive) or protein (positive).
- Had clinically abnormal ECG or Chest X-ray.
- Had history of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or haematological disease, diabetes or glaucoma.
- Had history of any psychiatric illness, which may impair the ability to provide, written informed consent.
- Were regular smokers who smoke more than 10 cigarettes daily or have difficulty abstaining from smoking for the duration of each study period.
- Had 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.
- Had used any enzyme modifying drugs within 30 days prior to Day 1 of this study.
- Had participated in any clinical trial within 12 weeks preceding Day 1 of this study.
- Subjects who, through completion of this study, would have donated and/or lost more than 350 mL of blood in the past 3 months.
About this study
Official title: An Open Label, Balanced, Randomized, Two-Treatment, Two-Period, Two- Sequence, Single-Dose, Crossover Bioavailability Study Comparing Hydrochlorothiazide 50 mg Tablet of Ohm Laboratories (A Subsidiary of Ranbaxy Pharmaceuticals USA) With Hydrochlorothiazide 50 mg Tablet of IVAX Pharmaceuticals in Healthy, Adult, Human, Male Subjects Under Fasting Condition
To compare the single-dose oral bioavailability of hydrochlorothiazide 50 mg tablet of Ohm Laboratories (A subsidiary of Ranbaxy pharmaceuticals USA) with hydrochlorothiazide 50 mg tablet of IVAX Pharmaceuticals, USA in healthy, adult, human, male subjects under fasting condition
Read the detailed description
The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two- sequence, single-dose, crossover bioavailability study comparing hydrochlorothiazide 50 mg tablet, containing 50 mg of hydrochlorothiazide of Ohm Laboratories (A subsidiary of Ranbaxy pharmaceuticals USA) with hydrochlorothiazide 50 mg tablet, containing 50 mg of hydrochlorothiazide of IVAX Pharmaceuticals, in healthy, adult, human, male subjects under fasting condition.
During the course of the study safety parameters assessed were vital signs, clinical examination, medical history and clinical laboratory safety tests (hematology, biochemical, serology parameters and urine analysis) at base line. Laboratory parameters of hematology and biochemistry were repeated at the end of the study. In addition serum electrolytes Sodium, Potassium and Chloride were measured on admission and at the discharge of each period.
A total of 36 subjects were randomized to receive single oral dose of hydrochlorothiazide 50 mg tablet and 31 subjects completed both the periods of the study.
- Conditions
- Healthy
- Being tested
- hydrochlorothiazide 50 mg tablet
- Keywords
- bioequivalence hydrochlorothiazide 50 mg tablet fasting conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrochlorothiazide 50 mg tabletDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | hydrochlorothiazide 50 mg tablet Receives: Drug: hydrochlorothiazide 50 mg tablet |
| 2 | Active comparator | hydrochlorothiazide 50 mg tablet Receives: Drug: hydrochlorothiazide 50 mg tablet |
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 posted21 Oct 2008 (estimated)
- Study startMay 2006
- Primary completionJun 2006
- Study completionAug 2006
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)
- Collaborators
- IPCA Laboratories Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00776646
- Sponsor's protocol ID
- 107_HYDRO¬_06
- Status last verified
- Oct 2008
- First submitted
- 20 Oct 2008
- Last updated
- 21 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Balanced, Randomized, Two-Treatment, Two-Period, Two- Sequence, Single-Dose, Crossover Bioavailability Study Comparing Hydrochlorothiazide 50 mg Tablet of Ohm Laboratories (A Subsidiary of Ranbaxy Pharmaceuticals USA) With Hydrochlorothiazide 50 mg Tablet of IVAX Pharmaceuticals in Healthy, Adult, Human, Male Subjects Under Fasting Condition
- ClinicalTrials.gov ID
- NCT00776646
- Acronym / sponsor ID
- 107_HYDRO¬_06
- Conditions
- Healthy
- Keywords
- bioequivalence hydrochlorothiazide 50 mg tablet fasting conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ranbaxy Laboratories LimitedIndustry (pharma, biotech, devices)
- Collaborators
- IPCA Laboratories Ltd.
- Study start
- May 2006
- Primary completion
- Jun 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 21 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 compare the single-dose oral bioavailability of hydrochlorothiazide 50 mg tablet of Ohm Laboratories (A subsidiary of Ranbaxy pharmaceuticals USA) with hydrochlorothiazide 50 mg tablet of IVAX Pharmaceuticals, USA in healthy, adult, human, male subjects under fasting condition
Detailed description
The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two- sequence, single-dose, crossover bioavailability study comparing hydrochlorothiazide 50 mg tablet, containing 50 mg of hydrochlorothiazide of Ohm Laboratories (A subsidiary of Ranbaxy pharmaceuticals USA) with hydrochlorothiazide 50 mg tablet, containing 50 mg of hydrochlorothiazide of IVAX Pharmaceuticals, in healthy, adult, human, male subjects under fasting condition.
During the course of the study safety parameters assessed were vital signs, clinical examination, medical history and clinical laboratory safety tests (hematology, biochemical, serology parameters and urine analysis) at base line. Laboratory parameters of hematology and biochemistry were repeated at the end of the study. In addition serum electrolytes Sodium, Potassium and Chloride were measured on admission and at the discharge of each period.
A total of 36 subjects were randomized to receive single oral dose of hydrochlorothiazide 50 mg tablet and 31 subjects completed both the periods of the study.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: hydrochlorothiazide 50 mg tablethydrochlorothiazide 50 mg tablet |
| 2 | Active comparator | Drug: hydrochlorothiazide 50 mg tablethydrochlorothiazide 50 mg tablet |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 18-45 years.
- Were neither overweight nor underweight for his height as per the Life Insurance Corporation of India height/weight chart for non-medical cases.
- Had voluntarily given written informed consent to participate in this study.
- Were of normal health as determined by medical history and physical examination of the subjects performed within 21 days prior to the commencement of the study.
Key exclusion criteria (27 listed)
- - Had history of allergy or hypersensitivity to hydrochlorothiazide or any other sulphonamide derived drugs.
- Had history of diarrhoea, vomiting or headache within past two weeks
- Had history of hypotension (systolic BP<100 mmHg)
- Had history of allergy or bronchial asthma
- Had history of muscle cramps or muscle weakness
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 |
|---|---|---|
| hydrochlorothiazide 50 mg tablet | 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 21 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 hydrochlorothiazide 50 mg tablet 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 4 inclusion and 27 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 21 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?
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 21 Oct 2008.