Asthma
Conditions
Brief summary
A study to evaluate the safety, tolerability and pharmacokinetics of inhaled Montelukast (MK-0476) in participants with mild or moderate asthma.
Interventions
DRUGMontelukast
Montelukast dry powder inhaler, 0.1 mg, 0.3 mg, 1 mg, 3 mg or 10 mg
DRUGPlacebo
Placebo dry powder inhaler
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female between the ages of 18 and 65 * Must have mild or moderate asthma (Part III only) * Nonsmoker for at least 6 months
Exclusion criteria
* History of stroke, chronic seizures or major neurological disorder * You are nursing * Drink more than 3 glasses of alcohol a day * Have allergy to or not able to tolerate lactose * Have a history of drug abuse in the last 5 years * Drink more than 6 beverages containing caffeine a day * Have had surgery, donated blood or participated in another investigational study in the last 4 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced At Least One Adverse Event | Up to 14 days after last dose of study drug | — |
| Number of Participants Who Discontinued Study Drug Due to an Adverse Event | Up to 7 days after last dose of study drug | — |
| Area Under the Curve From 0 to 24 Hours (AUC 0-24hr) of Montelukast - Single Dose | Up to 24 hours postdose | Blood samples for assessment of AUC 0-24hr were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I. |
| AUC 0-24hr of Montelukast - Multiple Doses | Up to 24 hours postdose | Blood samples for assessment of AUC 0-24hr were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III. |
| Maximum Plasma Concentration (Cmax) of Montelukast - Single Dose | Up to 24 hours postdose | Blood samples for assessment of Cmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I. |
| Cmax of Montelukast - Multiple Doses | Up to 24 hours postdose | Blood samples for assessment of Cmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III. |
| Time to Cmax (Tmax) of Montelukast - Single Dose | Up to 24 hours postdose | Blood samples for assessment of Tmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I. |
| Tmax of Montelukast - Multiple Doses | Up to 24 hours postdose | Blood samples for assessment of Tmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III. |
| Apparent Terminal Half Life (t1/2) of Montelukast - Single Dose | Up to 24 hours postdose | Blood samples for assessment of t1/2 were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I. |
| t1/2 of Montelukast - Multiple Doses | Up to 24 hours postdose | Blood samples for assessment of t1/2 were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III. |
| AUC 0-24hr Accumulation Ratio of Montelukast - Multiple Doses | up to 10 days after first dose of study drug | The AUC 0-24hr Accumulation Ratio of Montelukast was calculated as the geometric mean ratio of AUC 0-24hr on the last day and the first day of a multiple dose regimen: Day 5/Day 1 in Part II and Day 10/Day 1 in Part III. |
| Cmax Accumulation Ratio of Montelukast - Multiple Doses | up to 10 days after first dose of study drug | The Cmax Accumulation Ratio of Montelukast was calculated as the geometric mean ratio of Cmax on the last day and the first day of a multiple dose regimen: Day 5/Day 1 in Part II and Day 10/Day 1 in Part III. |
Participant flow
Recruitment details
Participants were recruited from 3 study sites located in the United States.
Participants by arm
| Arm | Count |
|---|---|
| Part I Part I consisted of 6 periods. Participants were to receive single doses of inhaled Montelukast (0.1 mg, 0.3 mg, 0.3 repeat, 1 mg, 3 mg or 10 mg) or Placebo. Each dose was separated by at least a 3-day washout period. | 9 |
| Part II Part II consisted of 3 periods. Participants in three serial panels (Panels A, B and C) were to receive once daily (QD) doses of inhaled Montelukast (1 mg, 3 mg or 10 mg) or Placebo administered for 5 consecutive days. Each panel was separated by at least a 3-day washout period. | 24 |
| Part III Part III consisted of 2 periods. Participants in two serial panels (Panels A and B) were to receive QD doses of inhaled Montelukast (3 mg or 10 mg) or Placebo administered for 10 consecutive days. Each panel was separated by at least a 7-day washout period. | 13 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Part I | Part II | Part III | Total |
|---|---|---|---|---|
| Age, Continuous | 37.4 years STANDARD_DEVIATION 10.45 | 31.0 years STANDARD_DEVIATION 12.68 | 36.3 years STANDARD_DEVIATION 10.32 | 33.8 years STANDARD_DEVIATION 11.78 |
| Sex: Female, Male Female | 2 Participants | 14 Participants | 6 Participants | 22 Participants |
| Sex: Female, Male Male | 7 Participants | 10 Participants | 7 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 7 | 4 / 7 | 6 / 12 | 9 / 18 | 5 / 19 | 6 / 18 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 | 0 / 12 | 0 / 18 | 0 / 19 | 0 / 18 |
Outcome results
Primary
Apparent Terminal Half Life (t1/2) of Montelukast - Single Dose
Blood samples for assessment of t1/2 were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.
Time frame: Up to 24 hours postdose
Population: Per Protocol Population: All participants who complied with the protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Montelukast 0.1 mg | Apparent Terminal Half Life (t1/2) of Montelukast - Single Dose | NA hours | — |
| Montelukast 0.3 mg | Apparent Terminal Half Life (t1/2) of Montelukast - Single Dose | NA hours | — |
| Montelukast 1 mg | Apparent Terminal Half Life (t1/2) of Montelukast - Single Dose | NA hours | — |
| Montelukast 3 mg | Apparent Terminal Half Life (t1/2) of Montelukast - Single Dose | 5.7 hours | Standard Deviation 2.1 |
| Montelukast 10 mg | Apparent Terminal Half Life (t1/2) of Montelukast - Single Dose | 6.9 hours | Standard Deviation 0.9 |
| Placebo | Apparent Terminal Half Life (t1/2) of Montelukast - Single Dose | 5.7 hours | Standard Deviation 0.5 |
Primary
Area Under the Curve From 0 to 24 Hours (AUC 0-24hr) of Montelukast - Single Dose
Blood samples for assessment of AUC 0-24hr were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.
Time frame: Up to 24 hours postdose
Population: Per Protocol Population: All participants who complied with the protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Montelukast 0.1 mg | Area Under the Curve From 0 to 24 Hours (AUC 0-24hr) of Montelukast - Single Dose | NA ng/mL*hr | — |
| Montelukast 0.3 mg | Area Under the Curve From 0 to 24 Hours (AUC 0-24hr) of Montelukast - Single Dose | NA ng/mL*hr | — |
| Montelukast 1 mg | Area Under the Curve From 0 to 24 Hours (AUC 0-24hr) of Montelukast - Single Dose | NA ng/mL*hr | — |
| Montelukast 3 mg | Area Under the Curve From 0 to 24 Hours (AUC 0-24hr) of Montelukast - Single Dose | 155 ng/mL*hr | Standard Deviation 18.5 |
| Montelukast 10 mg | Area Under the Curve From 0 to 24 Hours (AUC 0-24hr) of Montelukast - Single Dose | 491 ng/mL*hr | Standard Deviation 71 |
| Placebo | Area Under the Curve From 0 to 24 Hours (AUC 0-24hr) of Montelukast - Single Dose | 1600 ng/mL*hr | Standard Deviation 260 |
Primary
AUC 0-24hr Accumulation Ratio of Montelukast - Multiple Doses
The AUC 0-24hr Accumulation Ratio of Montelukast was calculated as the geometric mean ratio of AUC 0-24hr on the last day and the first day of a multiple dose regimen: Day 5/Day 1 in Part II and Day 10/Day 1 in Part III.
Time frame: up to 10 days after first dose of study drug
Population: Per Protocol Population: All participants who complied with the protocol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Montelukast 0.1 mg | AUC 0-24hr Accumulation Ratio of Montelukast - Multiple Doses | Part II (n=6) | 1.61 ratio |
| Montelukast 0.1 mg | AUC 0-24hr Accumulation Ratio of Montelukast - Multiple Doses | Part III (n=6) | NA ratio |
| Montelukast 0.3 mg | AUC 0-24hr Accumulation Ratio of Montelukast - Multiple Doses | Part II (n=6) | 1.44 ratio |
| Montelukast 0.3 mg | AUC 0-24hr Accumulation Ratio of Montelukast - Multiple Doses | Part III (n=6) | 1.19 ratio |
| Montelukast 1 mg | AUC 0-24hr Accumulation Ratio of Montelukast - Multiple Doses | Part II (n=6) | 1.2 ratio |
| Montelukast 1 mg | AUC 0-24hr Accumulation Ratio of Montelukast - Multiple Doses | Part III (n=6) | 1.26 ratio |
Primary
AUC 0-24hr of Montelukast - Multiple Doses
Blood samples for assessment of AUC 0-24hr were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.
Time frame: Up to 24 hours postdose
Population: Per Protocol Population: All participants who complied with the protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Montelukast 0.1 mg | AUC 0-24hr of Montelukast - Multiple Doses | Part II Day 5 (n=6) | 214 ng/mL*hr | Standard Deviation 76.3 |
| Montelukast 0.1 mg | AUC 0-24hr of Montelukast - Multiple Doses | Part II Day 1 (n=6) | 132 ng/mL*hr | Standard Deviation 43.7 |
| Montelukast 0.1 mg | AUC 0-24hr of Montelukast - Multiple Doses | Part III Day 1 (n=6) | NA ng/mL*hr | — |
| Montelukast 0.1 mg | AUC 0-24hr of Montelukast - Multiple Doses | Part III Day 10 (n=6) | NA ng/mL*hr | — |
| Montelukast 0.3 mg | AUC 0-24hr of Montelukast - Multiple Doses | Part III Day 10 (n=6) | 526 ng/mL*hr | Standard Deviation 133 |
| Montelukast 0.3 mg | AUC 0-24hr of Montelukast - Multiple Doses | Part III Day 1 (n=6) | 357 ng/mL*hr | Standard Deviation 109 |
| Montelukast 0.3 mg | AUC 0-24hr of Montelukast - Multiple Doses | Part II Day 1 (n=6) | 403 ng/mL*hr | Standard Deviation 115 |
| Montelukast 0.3 mg | AUC 0-24hr of Montelukast - Multiple Doses | Part II Day 5 (n=6) | 576 ng/mL*hr | Standard Deviation 148 |
| Montelukast 1 mg | AUC 0-24hr of Montelukast - Multiple Doses | Part II Day 1 (n=6) | 1576 ng/mL*hr | Standard Deviation 380 |
| Montelukast 1 mg | AUC 0-24hr of Montelukast - Multiple Doses | Part II Day 5 (n=6) | 1850 ng/mL*hr | Standard Deviation 304 |
| Montelukast 1 mg | AUC 0-24hr of Montelukast - Multiple Doses | Part III Day 1 (n=6) | 1500 ng/mL*hr | Standard Deviation 521 |
| Montelukast 1 mg | AUC 0-24hr of Montelukast - Multiple Doses | Part III Day 10 (n=6) | 1880 ng/mL*hr | Standard Deviation 530 |
Primary
Cmax Accumulation Ratio of Montelukast - Multiple Doses
The Cmax Accumulation Ratio of Montelukast was calculated as the geometric mean ratio of Cmax on the last day and the first day of a multiple dose regimen: Day 5/Day 1 in Part II and Day 10/Day 1 in Part III.
Time frame: up to 10 days after first dose of study drug
Population: Per Protocol Population: All participants who complied with the protocol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Montelukast 0.1 mg | Cmax Accumulation Ratio of Montelukast - Multiple Doses | Part II (n=6) | 1.73 ratio |
| Montelukast 0.1 mg | Cmax Accumulation Ratio of Montelukast - Multiple Doses | Part III (n=6) | NA ratio |
| Montelukast 0.3 mg | Cmax Accumulation Ratio of Montelukast - Multiple Doses | Part II (n=6) | 1.27 ratio |
| Montelukast 0.3 mg | Cmax Accumulation Ratio of Montelukast - Multiple Doses | Part III (n=6) | 1.03 ratio |
| Montelukast 1 mg | Cmax Accumulation Ratio of Montelukast - Multiple Doses | Part II (n=6) | 1.03 ratio |
| Montelukast 1 mg | Cmax Accumulation Ratio of Montelukast - Multiple Doses | Part III (n=6) | 1.22 ratio |
Primary
Cmax of Montelukast - Multiple Doses
Blood samples for assessment of Cmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.
Time frame: Up to 24 hours postdose
Population: Per Protocol Population: All participants who complied with the protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Montelukast 0.1 mg | Cmax of Montelukast - Multiple Doses | Part II Day 1 (n=6) | 13.8 ng/mL | Standard Deviation 4.96 |
| Montelukast 0.1 mg | Cmax of Montelukast - Multiple Doses | Part II Day 5 (n=6) | 23.4 ng/mL | Standard Deviation 6.5 |
| Montelukast 0.1 mg | Cmax of Montelukast - Multiple Doses | Part III Day 1 (n=6) | NA ng/mL | — |
| Montelukast 0.1 mg | Cmax of Montelukast - Multiple Doses | Part III Day 10 (n=6) | NA ng/mL | — |
| Montelukast 0.3 mg | Cmax of Montelukast - Multiple Doses | Part III Day 10 (n=6) | 64.8 ng/mL | Standard Deviation 13 |
| Montelukast 0.3 mg | Cmax of Montelukast - Multiple Doses | Part II Day 1 (n=6) | 60 ng/mL | Standard Deviation 13.1 |
| Montelukast 0.3 mg | Cmax of Montelukast - Multiple Doses | Part III Day 1 (n=6) | 44.3 ng/mL | Standard Deviation 16.6 |
| Montelukast 0.3 mg | Cmax of Montelukast - Multiple Doses | Part II Day 5 (n=6) | 76 ng/mL | Standard Deviation 15.3 |
| Montelukast 1 mg | Cmax of Montelukast - Multiple Doses | Part III Day 10 (n=6) | 225 ng/mL | Standard Deviation 84.7 |
| Montelukast 1 mg | Cmax of Montelukast - Multiple Doses | Part II Day 5 (n=6) | 242 ng/mL | Standard Deviation 38 |
| Montelukast 1 mg | Cmax of Montelukast - Multiple Doses | Part III Day 1 (n=6) | 184 ng/mL | Standard Deviation 66.6 |
| Montelukast 1 mg | Cmax of Montelukast - Multiple Doses | Part II Day 1 (n=6) | 233 ng/mL | Standard Deviation 30.2 |
Primary
Maximum Plasma Concentration (Cmax) of Montelukast - Single Dose
Blood samples for assessment of Cmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.
Time frame: Up to 24 hours postdose
Population: Per Protocol Population: All participants who complied with the protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Montelukast 0.1 mg | Maximum Plasma Concentration (Cmax) of Montelukast - Single Dose | NA ng/mL | — |
| Montelukast 0.3 mg | Maximum Plasma Concentration (Cmax) of Montelukast - Single Dose | 5.10 ng/mL | Standard Deviation 0.977 |
| Montelukast 1 mg | Maximum Plasma Concentration (Cmax) of Montelukast - Single Dose | 5.24 ng/mL | Standard Deviation 0.914 |
| Montelukast 3 mg | Maximum Plasma Concentration (Cmax) of Montelukast - Single Dose | 18.5 ng/mL | Standard Deviation 4.15 |
| Montelukast 10 mg | Maximum Plasma Concentration (Cmax) of Montelukast - Single Dose | 54.3 ng/mL | Standard Deviation 12.7 |
| Placebo | Maximum Plasma Concentration (Cmax) of Montelukast - Single Dose | 224 ng/mL | Standard Deviation 47.3 |
Primary
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
Time frame: Up to 7 days after last dose of study drug
Population: Safety Population: All participants who received at least one dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Montelukast 0.1 mg | Number of Participants Who Discontinued Study Drug Due to an Adverse Event | 0 participants |
| Montelukast 0.3 mg | Number of Participants Who Discontinued Study Drug Due to an Adverse Event | 1 participants |
| Montelukast 1 mg | Number of Participants Who Discontinued Study Drug Due to an Adverse Event | 0 participants |
| Montelukast 3 mg | Number of Participants Who Discontinued Study Drug Due to an Adverse Event | 0 participants |
| Montelukast 10 mg | Number of Participants Who Discontinued Study Drug Due to an Adverse Event | 0 participants |
| Placebo | Number of Participants Who Discontinued Study Drug Due to an Adverse Event | 0 participants |
Primary
Number of Participants Who Experienced At Least One Adverse Event
Time frame: Up to 14 days after last dose of study drug
Population: Safety Population: All participants who received at least one dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Montelukast 0.1 mg | Number of Participants Who Experienced At Least One Adverse Event | 2 participants |
| Montelukast 0.3 mg | Number of Participants Who Experienced At Least One Adverse Event | 4 participants |
| Montelukast 1 mg | Number of Participants Who Experienced At Least One Adverse Event | 6 participants |
| Montelukast 3 mg | Number of Participants Who Experienced At Least One Adverse Event | 9 participants |
| Montelukast 10 mg | Number of Participants Who Experienced At Least One Adverse Event | 5 participants |
| Placebo | Number of Participants Who Experienced At Least One Adverse Event | 6 participants |
Primary
t1/2 of Montelukast - Multiple Doses
Blood samples for assessment of t1/2 were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.
Time frame: Up to 24 hours postdose
Population: Per Protocol Population: All participants who complied with the protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Montelukast 0.1 mg | t1/2 of Montelukast - Multiple Doses | Part III Day 10 (n=6) | NA hours | — |
| Montelukast 0.1 mg | t1/2 of Montelukast - Multiple Doses | Part II Day 5 (n=6) | 8.2 hours | Standard Deviation 2.5 |
| Montelukast 0.3 mg | t1/2 of Montelukast - Multiple Doses | Part II Day 5 (n=6) | 7.6 hours | Standard Deviation 2.5 |
| Montelukast 0.3 mg | t1/2 of Montelukast - Multiple Doses | Part III Day 10 (n=6) | 8.1 hours | Standard Deviation 1.4 |
| Montelukast 1 mg | t1/2 of Montelukast - Multiple Doses | Part II Day 5 (n=6) | 7.7 hours | Standard Deviation 2.4 |
| Montelukast 1 mg | t1/2 of Montelukast - Multiple Doses | Part III Day 10 (n=6) | 7.4 hours | Standard Deviation 1.7 |
Primary
Time to Cmax (Tmax) of Montelukast - Single Dose
Blood samples for assessment of Tmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.
Time frame: Up to 24 hours postdose
Population: Per Protocol Population: All participants who complied with the protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Montelukast 0.1 mg | Time to Cmax (Tmax) of Montelukast - Single Dose | NA hours |
| Montelukast 0.3 mg | Time to Cmax (Tmax) of Montelukast - Single Dose | 2.5 hours |
| Montelukast 1 mg | Time to Cmax (Tmax) of Montelukast - Single Dose | 4.0 hours |
| Montelukast 3 mg | Time to Cmax (Tmax) of Montelukast - Single Dose | 2.4 hours |
| Montelukast 10 mg | Time to Cmax (Tmax) of Montelukast - Single Dose | 0.8 hours |
| Placebo | Time to Cmax (Tmax) of Montelukast - Single Dose | 0.5 hours |
Primary
Tmax of Montelukast - Multiple Doses
Blood samples for assessment of Tmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.
Time frame: Up to 24 hours postdose
Population: Per Protocol Population: All participants who complied with the protocol
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Montelukast 0.1 mg | Tmax of Montelukast - Multiple Doses | Part II Day 1 (n=6) | 2.4 hours |
| Montelukast 0.1 mg | Tmax of Montelukast - Multiple Doses | Part II Day 5 (n=6) | 0.7 hours |
| Montelukast 0.1 mg | Tmax of Montelukast - Multiple Doses | Part III Day 1 (n=6) | NA hours |
| Montelukast 0.1 mg | Tmax of Montelukast - Multiple Doses | Part III Day 10 (n=6) | NA hours |
| Montelukast 0.3 mg | Tmax of Montelukast - Multiple Doses | Part III Day 10 (n=6) | 0.5 hours |
| Montelukast 0.3 mg | Tmax of Montelukast - Multiple Doses | Part II Day 1 (n=6) | 0.5 hours |
| Montelukast 0.3 mg | Tmax of Montelukast - Multiple Doses | Part III Day 1 (n=6) | 0.5 hours |
| Montelukast 0.3 mg | Tmax of Montelukast - Multiple Doses | Part II Day 5 (n=6) | 0.5 hours |
| Montelukast 1 mg | Tmax of Montelukast - Multiple Doses | Part III Day 10 (n=6) | 0.5 hours |
| Montelukast 1 mg | Tmax of Montelukast - Multiple Doses | Part II Day 5 (n=6) | 0.6 hours |
| Montelukast 1 mg | Tmax of Montelukast - Multiple Doses | Part III Day 1 (n=6) | 0.5 hours |
| Montelukast 1 mg | Tmax of Montelukast - Multiple Doses | Part II Day 1 (n=6) | 0.5 hours |