Healthy Male VolunteersPhase 1NCT01356043
CKD-828 Drug Interaction Study (S-amlodipine)
A Phase 1 study testing S-amlodipine 5mg,Telmisartan 80mg and S-amlodipine 5mg in people with Healthy Male Volunteers, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the Pharmacokinetic drug interaction and safety of S-amlodipine between free combination of S-amlodipine and Telmisartan and S-amlodipine monotherapy. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Volunteers
- What is being tested?
- S-amlodipine 5mg,Telmisartan 80mg and S-amlodipine 5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2011to Aug 2011
- 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 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 20 aged and 50 aged in healthy males
- Weight more than 55kg, BMI 19kg/m2-26kg/m2 at the period of screening
- 100mmHg ≤ sit SBP < 140mmHg and 60mmHg ≤ sit DBP < 90mmHg and 50 per/min ≤ Pulse rate < 95 per/min
- AST, ALT, Total bilirubin < UNL x 1.5
- Signed the informed consent from prior to the study participation
Who cannot join
- Have history of significant hepatic, renal, gastrointestinal, pulmonary, musculoskeletal, endocrine, neuropsychiatric, hematologic, cardiovascular diseases
- Have a gastrointestinal disease(ex : Crohn's disease, gastrointestinal ulcer) or surgery(except for Appendectomy, Hernia repair) affected by the absorption of medications
- galactose intolerance or Lapp lactase deficiency or glucose-galactose malabsorption
- Hypersensitivity reactions to drugs or clinically significant hypersensitivity reactions in the history of telmisartan or Amlodipine
- drug abuse, or have a history of drug abuse showed a positive for the Triage TOX drug on urine : amphetamine, barbiturate, cocaine, opiates, benzodiazepines, THC(cannabinoids), methadone etc.
- Subject who takes herbal medicine within 30 days, ethical drug within 14 days, OTC within 7 days before the beginning of study treatment
Show all 15Show fewer
- unusual diet affected by the absorption, distribution, metabolism, excretion of medications
- Subject who treated with any investigational drugs within 90 days before the beginning of study treatment
- Previously donate whole blood within 60 days or component blood within 30 days or transfusion within 30 days
- Subject who takes inhibitors and inducers of drug metabolizing enzyme(Barbiturates etc.) within 30 days
- A heavy caffeine consumer (caffeine > 5 units/day)
- A heavy alcohol consumer (alcohol > 21 units/week, 1 unit=pure alcohol 10mL) or cannot stop drinking
- A heavy smoker (cigarette > 20 cigarettes per day)
- Positive for Hepatitis B, Hepatitis C, HIV or syphilis
- An impossible one who participates in clinical trial by investigator's decision including laboratory test result, EKG result
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Multiple Doses, Crossover Study to Evaluate the Pharmacokinetic Drug Interaction and Safety of S-amlodipine Between Free Combination of S-amlodipine and Telmisartan and S-amlodipine Monotherapy in Healthy Male Volunteers
The purpose of this study is to evaluate the Pharmacokinetic drug interaction and safety of S-amlodipine between free combination of S-amlodipine and Telmisartan and S-amlodipine monotherapy.
- Conditions
- Healthy Male Volunteers
- Being tested
- S-amlodipine 5mg,Telmisartan 80mg, S-amlodipine 5mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-amlodipine 5mg,Telmisartan 80mgDrug
Also called Anydipine S 5mg, Micardis 80mg
S-amlodipine 5mg and Telmisartan 80mg, Oral, Once a day, for 9 days + Wash out (19 days)
S-amlodipine 5mgDrug
Also called Anydipine S 5mg
S-amlodipine 5mg, Oral, Once a day, for 9 days + Wash out(19 days)
| Study group | Role | What they receive |
|---|---|---|
| Free combination of S-amlodipine and Telmisartan | Experimental | Subjects received S-amlodipine 5mg and Telmisartan 80mg once a day for 9 days. And subjects doesn't take any medications for 19 days. Receives: Drug: S-amlodipine 5mg,Telmisartan 80mg |
| S-amlodipine monotherapy | Active comparator | Subjects received S-amlodipine 5mg once a day for 9 days. And subjects doesn't take any medications for 19 days. Receives: Drug: S-amlodipine 5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
S-amlodipine AUC
Measured: 0, 192, 193, 194, 195, 196, 197, 198, 199, 200, 202, 204, 206, 216 hr
Secondary outcomes (2)
S-amlodipine Cmax
Measured: 0, 192, 193, 194, 195, 196, 197, 198, 199, 200, 202, 204, 206, 216 hr
S-amlodipine Tmax
Measured: 0, 192, 193, 194, 195, 196, 197, 198, 199, 200, 202, 204, 206, 216 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2011 (estimated)
- Study startMay 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Male VolunteersStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Asan Medical Center
- Investigators
- Kyun S Bae, Ph.D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01356043
- Sponsor's protocol ID
- 130HPS11D
- Status last verified
- Aug 2011
- First submitted
- 17 May 2011
- Last updated
- 30 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Noh YH, Lim HS, Kim MJ, Kim YH, Choi HY, Sung HR, Jin SJ, Lim J, Bae KS. Pharmacokinetic interaction of telmisartan with s-amlodipine: an open-label, two-period crossover study in healthy Korean male volunteers. Clin Ther. 2012 Jul;34(7):1625-35. doi: 10.1016/j.clinthera.2012.05.010. Epub 2012 Jun 19.
PubMed 22721873
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multiple Doses, Crossover Study to Evaluate the Pharmacokinetic Drug Interaction and Safety of S-amlodipine Between Free Combination of S-amlodipine and Telmisartan and S-amlodipine Monotherapy in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01356043
- Acronym / sponsor ID
- 130HPS11D
- Conditions
- Healthy Male Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Collaborators
- Asan Medical Center
- Study start
- May 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 19 May 2011 (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 evaluate the Pharmacokinetic drug interaction and safety of S-amlodipine between free combination of S-amlodipine and Telmisartan and S-amlodipine monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Free combination of S-amlodipine and Telmisartan | Experimental | Drug: S-amlodipine 5mg,Telmisartan 80mgSubjects received S-amlodipine 5mg and Telmisartan 80mg once a day for 9 days. And subjects doesn't take any medications for 19 days. |
| S-amlodipine monotherapy | Active comparator | Drug: S-amlodipine 5mgSubjects received S-amlodipine 5mg once a day for 9 days. And subjects doesn't take any medications for 19 days. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Between 20 aged and 50 aged in healthy males
- Weight more than 55kg, BMI 19kg/m2-26kg/m2 at the period of screening
- 100mmHg ≤ sit SBP < 140mmHg and 60mmHg ≤ sit DBP < 90mmHg and 50 per/min ≤ Pulse rate < 95 per/min
- AST, ALT, Total bilirubin < UNL x 1.5
- Signed the informed consent from prior to the study participation
Key exclusion criteria (15 listed)
- Have history of significant hepatic, renal, gastrointestinal, pulmonary, musculoskeletal, endocrine, neuropsychiatric, hematologic, cardiovascular diseases
- Have a gastrointestinal disease(ex : Crohn's disease, gastrointestinal ulcer) or surgery(except for Appendectomy, Hernia repair) affected by the absorption of medications
- galactose intolerance or Lapp lactase deficiency or glucose-galactose malabsorption
- Hypersensitivity reactions to drugs or clinically significant hypersensitivity reactions in the history of telmisartan or Amlodipine
- drug abuse, or have a history of drug abuse showed a positive for the Triage TOX drug on urine : amphetamine, barbiturate, cocaine, opiates, benzodiazepines, THC(cannabinoids), methadone etc.
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 |
|---|---|---|
| S-amlodipine 5mg,Telmisartan 80mgAlso: Anydipine S 5mg, Micardis 80mgS-amlodipine 5mg and Telmisartan 80mg, Oral, Once a day, for 9 days + Wash out (19 days) | Drug | Free combination of S-amlodipine and Telmisartan |
| S-amlodipine 5mgAlso: Anydipine S 5mgS-amlodipine 5mg, Oral, Once a day, for 9 days + Wash out(19 days) | Drug | S-amlodipine monotherapy |
Primary outcome
S-amlodipine AUC
Time frame: 0, 192, 193, 194, 195, 196, 197, 198, 199, 200, 202, 204, 206, 216 hr
2 secondary outcomes
S-amlodipine Cmax
Time frame: 0, 192, 193, 194, 195, 196, 197, 198, 199, 200, 202, 204, 206, 216 hr
S-amlodipine Tmax
Time frame: 0, 192, 193, 194, 195, 196, 197, 198, 199, 200, 202, 204, 206, 216 hr
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 30 Aug 2011.
- Derived from this study: PubMed 22721873Noh YH, Lim HS, Kim MJ, Kim YH, Choi HY, Sung HR, Jin SJ, Lim J, Bae KS. Pharmacokinetic interaction of telmisartan with s-amlodipine: an open-label, two-period crossover study in healthy Korean male volunteers. Clin Ther. 2012 Jul;34(7):1625-35. doi: 10.1016/j.clinthera.2012.05.010. Epub 2012 Jun 19.
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Health Volunteers
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.
Kyun S Bae, Ph.D. principal investigator
Asan Medical Center
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 S-amlodipine 5mg,Telmisartan 80mg and S-amlodipine 5mg in people with Healthy Male Volunteers, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
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 5 inclusion and 15 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 30 Aug 2011. 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 South Korea. 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?
S-amlodipine AUC (time frame: 0, 192, 193, 194, 195, 196, 197, 198, 199, 200, 202, 204, 206, 216 hr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01356043, which also lists 1 linked publication.
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 30 Aug 2011.